Patent Terms Extended Under 35 USC §156

NOTE: This list is for informational purposes only and is not intended to have legal effect. Furthermore, this list does not include patents which have been extended only under § 156(e)(2) or § 156(d)(5) (patents which have only received an interim extension). Each patent number is hyperlinked to a copy of its certificate of extension, if available. A copy of the certificate of extension should be included in the "correction" section of the patent's images. See http://www.uspto.gov/patft/index.html to access the patent image database. Items shown in a bold red font are new relative to the last version of this web page.

For further information, contact Mary C. Till, at (571) 272-7755 (telephone) or by e-mail at: mary.till@uspto.gov.

Please note that many patent term extension applications are available on PUBLIC PAIR; see http://portal.uspto.gov/external/portal/pair.

Additional information concerning patent expiration dates of human drug products can be obtained from the Food and Drug Administration, Center for Drug Evaluation and Research. The Patent and Exclusivity Addendum of the "Orange Book" the Approved Drug Products with Therapeutic Equivalents Evaluations includes an alphabetical listing of human drug products according to generic name with related patent information. The "Electronic Orange Book," a searchable version of the Orange Book, is available at: http://www.fda.gov/cder/ob/default.htm.

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Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
RE 27,757 CARDIOVERTER/
DEFIBRILLATOR SYSTEM
26-Oct-88 2 years 26-Oct-90
RE 30,577 BEPADIN/VASCOR 08-Jun-93 2 years 08-Jun-95
RE 30,633 DEMADEX 19-Apr-94 5 years 19-Apr-99
RE 30,811 ENKAID 20-Dec-94 2 years 20-Dec-96
RE 30,910 DEURSIL 07-Jan-92 2 years 07-Jan-94
RE 31,244 PINDAC 08-Nov-94 2 years 08-Nov-96
RE 32,969 ORCOLON 14-Oct-02 897 days* 29-Mar-91 29-Mar-05
RE 33,653 PROLEUKIN 19-Oct-02 1,294 days* 05-May-92 05-May-06
RE 34,440 DIFFERIN 24-Mar-09 433 days 31-May-96 31-May-10
RE 34,712 LEXAPRO 08-Jun-09 828 days 14-Sep-11
RE 34,617 OLEAN 12-Feb-96 2 years*** 30-Jan-96 12-Feb-98
RE 34,878 STARLIX 28-Mar-06 1,260 days 08-Sep-09
RE 35,524 ETOPOPHOS 04-Aug-07 1,017 days 17-May-96 17-May-10
RE 36,128 AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION 27-Mar-07 1,390 days 15-Jan-97 15-Jan-11
RE 36,755 ENBREL 07-Mar-12 230 days 23-Oct-12
RE 37,035 PRANDIN 05-Sep-06 921 days 14-Mar-09
RE 37,314 CRESTOR 12-Jun-12 1,305 days 08-Jan-16
RE 37,721 ZETIA 16-Jun-15 497 days* 25-Oct-02 24-Oct-16
RE 37,806 XIGRIS 28-Oct-14 389 days 21-Nov-01 21-Nov-15
RE 39,128 ALTABAX OINTMENT 27-Oct-18 898 days* 12-Apr-07 12-Apr-21
RE 39,198 FANAPT 15-Nov-11 5 years 15-Nov-16
RE 39,593 TAPENTADOL HYDROCHLORIDE 19-Jun-18 1,508 days 05-Aug-22
RE 39,820 SPIRIVA HANDIHALER 11-Mar-14 1,421 days* 30-Jan-04 30-Jan-18
3,577,424 MERITAL CAPSULES 04-May-88 2 years 04-May-90
3,632,645 TENEX 04-Jan-89 2 years 04-Jan-91
3,641,127 ORUDIS 08-Feb-89 2 years 08-Feb-91
3,649,691 BETAFAN 14-Mar-89 2 years 14-Mar-91
3,652,762 VOLTAREN 28-Mar-89 2 years 28-Mar-91
3,681,500 ATROVENT 01-Aug-89 2 years 01-Aug-91
3,708,579 RIDAURA CAPSULES 02-Jan-90 2 years 02-Jan-92
3,721,687 TEMOVATE 20-Mar-90 2 years 20-Mar-92
3,732,340 IFEX 08-May-90 2 years 08-May-92
3,737,433 TRENTAL 05-Jun-90 2,494 days 03-Apr-97
3,786,160 EXIREL 15-Jan-91 2 years 15-Jan-93
3,789,832 BETA 3000 NMR SCANNING DEVICE 05-Feb-91 382 days 22-Feb-92
3,793,457 OCUFEN 19-Feb-91 2 years 19-Feb-93
3,842,061 ANTITHROBIN III 15-Oct-91 5 years 15-Oct-96
3,856,935 TYPHOID VACCINE TY21A 24-Dec-89 2 years 24-Dec-91
3,857,952 SECTRAL TABLETS 17-Dec-91 2 years 17-Dec-93
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
3,864,487 ETHMOZINE 04-Feb-92 2 years 04-Feb-94
3,878,217 SELDANE TABLETS 15-Apr-92 2 years 15-Apr-94
3,885,046 WELLBUTRIN 20-May-92 2 years 20-May-94
3,896,145 RIMADYL 22-Jul-92 2 years 22-Jul-94
3,910,924 CARTROL 07-Oct-92 2 years 07-Oct-94
3,911,138 FLUOSOL 07-Oct-92 2 years 07-Oct-94
3,920,818 DORMALIN 18-Nov-92 2 years 18-Nov-94
3,927,046 DESOGEN 16-Dec-92 1,069 days 20-Nov-95
3,929,971 PRO OSTEON 500 30-Dec-92 2 years 30-Dec-94
3,954,872 MEXITIL CAPSULES 04-May-93 2 years 04-May-95
3,957,764 COACTIN 18-May-93 2 years 18-May-95
3,962,248 CLOZARIL 08-Jun-93 2 years 08-Jun-95
3,962,432 AREDIA 08-Jun-93 1,133 days 15-Jul-96
3,965,143 CYTOTEC 22-Jun-93 2 years 22-Jun-95
3,975,512 IMAGENT GI 17-Aug-93 2 years 17-Aug-95
3,985,758 CARDENE 12-Oct-93 2 years 12-Oct-95
3,987,052 PRO SOM 19-Oct-93 2 years 19-Oct-95
3,998,790 LOPRESSOR OROS 21-Dec-93 2 years 21-Dec-95
4,001,323 IOPAMIDOL 04-Jan-94 2 years 04-Jan-96
4,001,331 DALGAN 04-Jan-94 2 years 04-Jan-96
4,005,063 LUPRON INJECTION 25-Jan-94 2 years 25-Jan-96
4,005,209 TAMBOCOR 25-Jan-94 2 years 25-Jan-96
4,006,220 FIBREL 01-Feb-94 2 years 01-Feb-96
4,012,444 LABETALOL 15-Mar-94 1,600 days 01-Aug-84 01-Aug-98
4,014,986 HEXABRIX 29-Mar-94 2 years 29-Mar-96
4,024,163 NIX 17-May-94 2 years 17-May-96
4,024,251 PRODUCIL 17-May-94 3 years 17-May-97
4,027,019 ORTHO-CYCLEN 31-May-94 2 years 31-May-96
4,035,376 SUPROFEN 12-Jul-94 2 years 12-Jul-96
4,046,878 IDAMYCIN 06-Sep-94 2 years 06-Sep-96
4,048,306 DYNABAC 29-Mar-97 1,626 days 10-Sep-01
4,051,141 TICLID 27-Sep-94 2 years 27-Sep-96
4,052,991 PCD TACHYARRHYTHMIA CONTROL DEVICE MODEL 72171B 11-Oct-94 808 days 27-Dec-96
4,055,652 SULCOSYN SOLUTION 25-Oct-94 2 years 25-Oct-96
4,056,635 DIPRIVAN 01-Nov-94 2 years 01-Nov-96
4,062,848 REMERON 13-Dec-94 2 years*** 14-Jun-96 14-Jun-98
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,071,536 BACTROBAN 31-Jan-95 2 years 31-Jan-97
4,072,746 AMRINONE LACTATE 07-Feb-95 1,270 days 31-Jul-98
4,076,831 LODINE 28-Feb-95 2 years 28-Feb-97
4,078,071 FEMSTAT 07-Mar-95 2 years 07-Mar-97
4,080,458 EQUESTROLIN 21-Mar-95 3 years 21-Mar-98
4,080,461 SYNANTHIC 21-Mar-95 3 years 21-Mar-98
4,085,225 LUVOX 18-Apr-95 2 years 18-Apr-97
4,087,544 NEURONTIN 02-May-95 1,720 days 16-Jan-00
4,087,545 CESAMET 02-May-95 2 years 02-May-97
4,089,969 TORADOL 16-May-95 2 years 16-May-97
4,096,127 ANIONIC POLYURETHANE 27-Jul-93 2 years 27-Jul-95
4,100,274 ZOLADEX 22-Apr-97 2 years 22-Apr-99
4,105,783 LAC-HYDRIN 03-May-94 541 days 26-Oct-95
4,138,581 TONOLATE 06-Feb-96 2 years 06-Feb-98
4,140,707 PARAPLATIN 20-Feb-96 916 days 24-Aug-98
4,146,029 SYNCHROMED INFUSION
PUMP
02-Dec-92 2 years 02-Dec-94
4,146,719 NOROXIN 16-Feb-98 2 years 16-Feb-00
4,154,839 NISOCOR 02-Nov-96 2 years 02-Nov-98
4,156,724 CEFPIRAMIDE SODIUM 29-May-96 2 years 29-May-98
4,158,068 ACESULFAME POTASSIUM 22-Jun-97 2 years 22-Jun-99
4,166,182 PERMAX 08-Feb-98 2 years 08-Feb-00
4,167,574 ALFENTA 05-May-97 2 years 05-May-99
4,182,763 BUSPAR 22-May-98 2 years 22-May-00
4,188,390 CARDURA 18-Oct-98 2 years 18-Oct-00
4,190,584 DAYPRO 08-Aug-97 2 years 08-Aug-99
4,194,047 PRIMAXIN 18-Mar-97 2 years 18-Mar-99
4,197,297 CORLOPAM 08-Apr-97 2 years*** 23-Sep-97 23-Sep-99
4,199,569 STROMECTOL 3-Oct-97 1,291 days 16-Apr-01
4,201,772 PROMIT 28-Mar-98 216 days* 30-Oct-84 30-Oct-98
4,209,430 SYLVACOTE K 24-Nov-98 2 years 24-Nov-00
4,211,771 VIRAZOLE 08-Jul-97 2 years 08-Jul-99
4,215,113 FOSCAVIR 29-Jul-97 1,042 days 05-Jun-00
4,215,215 TEGISON 29-Jul-97 2 years 29-Jul-99
4,219,478 MICOBUTIN 26-Aug-97 1,406 days 02-Jul-01
4,219,559 HISMANAL 03-Apr-98 2 years 03-Apr-00
4,220,660 MESNEX 06-Dec-98 821 days 06-Mar-01
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,224,946 NOVAFIL 14-Aug-98 412 days* 30-Sep-85 30-Sep-99
4,231,938 MEVACOR 15-Jun-99 2 years 15-Jun-01
4,234,571 SYNAREL 11-Jun-99 2 years 11-Jun-01
4,234,579 UNASYN 18-Nov-97 2 years 18-Nov-99
4,235,892 NUFLOR 05-Feb-99 3 years 05-Feb-02
4,237,068 TONOCARD 02-Dec-97 342 days 09-Nov-98
4,239,747 OSMOVIST 16-Dec-97 2 years 16-Dec-99
4,241,057 CERADON 23-Dec-97 2 years 23-Dec-99
4,242,334 DERMATOP 02-Aug-98 2 years 02-Aug-00
4,243,775 MAXON 06-Jan-98 2 years 06-Jan-00
4,244,946 SUPPRELIN 11-Jun-99 2 years 11-Jun-01
4,250,113 OMNIPAQUE 10-Feb-98 684 days 26-Dec-99
4,250,334 ULTANE 26-Dec-99 5 years 26-Dec-04
4,251,532 HYTRIN 17-Feb-98 2 years 17-Feb-00
4,252,721 REV-EYES 29-Mar-99 1,411 days 07-Feb-03
4,252,984 BETOPTIC 24-Feb-98 552 days 30-Aug-99
4,254,129 ALLEGRA 10-Apr-99 679 days 17-Feb-01
4,255,431 LOSEC 05-Apr-99 2 years 05-Apr-01
4,258,041 FORTAZ 25-May-99 55 days* 19-Jul-85 19-Jul-99
4,258,062 ZEBETA 24-Mar-98 2 years 24-Mar-00
4,260,769 CEREBYX 07-Apr-98 5 years 07-Apr-03
4,263,432 CEFOTAN 07-Jun-98 568 days* 27-Dec-85 27-Dec-99
4,264,500 RIMADYL 28-Feb-00 3 years 28-Feb-03
4,264,611 PLENDIL 19-Jun-99 2 years 19-Jun-01
4,267,179 SPORANOX 23-Jun-98 2 years 23-Jun-00
4,267,320 CEFTIN 12-May-98 2 years 12-May-00
4,275,063 ZINECARD 23-Jun-98 5 years 23-Jun-03
4,278,663 CYGRO 30-Jan-00 3 years 30-Jan-03
4,278,689 NOVANTRONE 14-Jul-98 2 years 14-Jul-00
4,278,789 PIRSUE AQUEOUS GEL 23-Nov-99 3 years 23-Nov-02
4,280,957 VERSED 28-Jul-98 510 days 20-Dec-99
4,282,233 CLARITIN 19-Jun-00 2 years 19-Jun-02
4,282,251 NAFTIN 04-Aug-98 2 years 04-Aug-00
4,283,408 PEPCID 27-Dec-99 293 days* 15-Oct-86 15-Oct-00
4,284,647 UCEPHAN 31-Mar-00 632 days* 23-Dec-87 23-Dec-01
4,285,932 EMINASE 20-Aug-99 2 years 20-Aug-01
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,290,962 PANDEL CREAM 26-Mar-99 5 years 26-Mar-04
4,291,708 T-Scan 2000 02-Nov-98 1,113 days 19-Nov-01
4,297,488 ZEFAZONE 27-Oct-98 2 years 27-Oct-00
4,298,607 CEFMAX 11-Dec-99 2 years 11-Dec-01
4,303,651 FRAGMIN 04-Jan-00 5 years 04-Jan-05
4,307,100 NAVELBINE 20-Aug-99 1,053 days 08-Jul-02
4,309,445 REDUX 16-Jun-00 1,343 days 19-Feb-04
4,309,778 NEW JERSEY KNEE 02-Jul-99 ** 12-Apr-85 not applicable
4,312,860 EXOSURF 24-Oct-00 1,030 days 20-Aug-03
4,313,951 COROTROPE 26-Nov-99 2 years 26-Nov-01
4,314,081 PROZAC 02-Feb-99 2 years 02-Feb-01
4,316,472 VENTAK P AICD MODEL 1600 23-Feb-99 740 days 04-Mar-01
4,316,839 MAZICON 03-Oct-00 1,468 days 10-Oct-04
4,326,052 KELCOGEL 20-Apr-99 2 years 20-Apr-01
4,328,592 DUROMEDICS CARDIAC VALVE PROSTHESIS 11-May-99 476 days 29-Aug-86 29-Aug-00
4,329,364 EULEXIN 11-May-99 2 years 11-May-01
4,331,803 BIAXIN 19-May-01 1,465 days 23-May-05
4,335,121 CUTIVATE OINTMENT 13-Feb-01 1,004 days 14-Nov-03
4,337,201 MONOPRIL 04-Dec-00 2 years 04-Dec-02
4,338,317 SERZONE 16-Mar-01 2 years 16-Mar-03
4,343,049 MONOSTRUT 10-Aug-99 2 years 10-Aug-01
4,344,949 ACCUPRIL 03-Oct-00 2 years 03-Oct-02
4,346,227 PRAVACHOL 05-Jun-01 1,598 days 20-Oct-05
4,347,198 ASTIFILAN A (SOFT CONTACT LENS) 31-Aug-99 146 days 24-Jan-00
4,355,032 CYTOVENE 21-May-01 763 days* 23-Jun-89 23-Jun-03
4,357,324 FLUDARA 24-Feb-01 2 years 24-Feb-03
4,358,449 TERAZOL 09-Nov-99 2 years 09-Nov-01
4,359,578 PENETREX 16-Nov-99 2 years 16-Nov-01
4,360,511 SPECTAMINE 23-Nov-99 2 years 23-Nov-01
4,361,549 MUROMONAB-DC3 30-Nov-99 201 days 18-Jun-00
4,362,567 TISSEEL VH KIT 04-Feb-00 2 years 04-Feb-02
4,364,921 ULTRAVIST 06-Mar-00 5 years 06-Mar-05
4,369,184 LIVOSTIN 24-Jan-00 1,779 days 07-Dec-04
4,374,829 PRINIVIL 22-Feb-00 676 days 29-Dec-01
4,375,547 AXID 02-Oct-00 557 days* 12-Apr-88 12-Apr-02
4,376,858 NEUTREXIN 31-Oct-00 1,286 days 09-May-04
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,379,785 AMARYL 17-Dec-00 1,571 days 06-Apr-05
4,382,892 FLOXIN 02-Sep-01 2 years 02-Sep-03
4,382,938 AMBIEN 21-Oct-01 5 years 21-Oct-06
4,387,089 PHOTOPLEX 07-Jun-00 2 years 07-Jun-02
4,395,403 SANDOSTATIN 21-Nov-00 699 days* 21-Oct-88 21-Oct-02
4,396,598 OPTIRAY 11-Jan-02 353 days* 30-Dec-88 30-Dec-02
4,397,839 SURVANTA 04-Mar-02 1,215 days* 01-Jul-91 01-Jul-05
4,400,358 CARDIOGEN-82 23-Aug-00 2 years 23-Aug-02
4,404,216 DIFLUCAN 01-Jun-02 607 days* 29-Jan-90 29-Jan-04
4,406,899 MAXIPIME 04-Mar-02 5 years 04-Mar-07
4,406,906 NIMOTOP 27-Sep-00 2 years 27-Sep-02
4,407,288 CPI VENTAK PRX AICD SYSTEM 11-Dec-00 1,107 days 23-Dec-03
4,409,214 SUPRAX 10-Nov-00 2 years 10-Nov-02
4,410,520 LOTENSIN 11-Aug-01 2 years 11-Aug-03
4,412,992 COLAZAL 08-Jul-01 5 years 08-Jul-06
4,418,208 CHOLETEC 29-Nov-00 53 days* 21-Jan-87 21-Jan-01
4,420,639 RELAFEN 13-Dec-00 2 years 13-Dec-02
4,427,663 IVOMEC/EPRINEX 16-Mar-02 1,255 days 16-Apr-97 22-Aug-05
4,428,744 THERAKOS UVAR SYSTEM 11-Dec-99 484 days* 08-Apr-87 08-Apr-01
4,430,343 EMADINE 22-Oct-02 1,027 days 14-Aug-05
4,431,665 CATALYST 50 TYPE A MEDICATED ARTICLE 14-Feb-01 3 years 14-Feb-04
4,431,829 ISMO 24-Jun-01 2 years 24-Jun-03
4,435,440 SUCRALOSE 06-Mar-01 2 years 06-Mar-03
4,443,466 DORMOSEDAN 17-Apr-01 954 days 27-Nov-03
4,444,784 ZOCOR 24-Apr-01 1,704 days 23-Dec-05
4,452,745 DECABID 05-Jun-01 2 years 05-Jun-03
4,452,774 CARDIOLITE 30-Apr-02 966 days* 21-Dec-90 21-Dec-04
4,452,808

REQUIP

07-Dec-02 5 years 07-Dec-07
4,455,297 ACEL-IMUNE 19-Jun-01 1,642 days 17-Dec-05
4,457,942 BUPHENYL POWDER 20-Aug-02 2 years 20-Aug-04
4,466,972 DYNA CIRC 21-Aug-01 2 years 21-Aug-03
4,470,972 RENORMAX 11-Sep-01 2 years 11-Sep-03
4,474,787 TILADE 02-Oct-01 5 years 02-Oct-06
4,477,615 UVASORB HA88 02-Jul-02 5 years 02-Jul-07
4,485,088 BAPTEN 26-Mar-02 3 years 26-Mar-05
4,485,096 APLIGRAF 27-Nov-01 5 years 27-Nov-06
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,490,351 VITREON 15-Mar-02 5 years 15-Mar-07
4,494,531 COOK BIRD'S NEST VENA CAVA FILTER 06-Dec-02 141 days* 26-Apr-88 26-Apr-03
4,503,067 COREG 05-Mar-02 5 years 05-Mar-07
4,508,729 ACEON 02-Apr-02 1,601 days 20-Aug-06
4,513,006 TOPAMAX 26-Sep-03 5 years 26-Sep-08
4,514,390 IMMITICIDE 30-Apr-02 1,632 days 18-Oct-06
4,517,359 ZITHROMAX 14-May-02 1,267 days 01-Nov-05
4,520,022 CEFZIL 28-Jan-03 1,060 days* 23-Dec-91 23-Dec-05
4,525,358 ZYRTEC 25-Jun-02 5 years 25-Jun-07
4,526,892 DOSTINEX 02-Jul-02 1,276 days 29-Dec-05
4,528,287 MAXAQUIN 17-Sep-04 522 days* 21-Feb-92 21-Feb-06
4,529,593 GANITE 22-Oct-02 818 days* 17-Jan-91 17-Jan-05
4,530,360 SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) 12-Nov-02 5 years 12-Nov-07
4,535,186 EFFEXOR 13-Dec-02 5 years 13-Dec-07
4,536,518 ZOLOFT 20-Aug-02 1,228 days* 30-Dec-91 30-Dec-05
4,543,954 SENSOR MODEL 19-May-02 ** 29-Apr-88 not applicable
4,544,664 DOMITOR 11-Feb-01 3 years 11-Feb-04
4,547,520 INTERCEPTOR 25-Nov-03 202 days* 14-Jun-90 14-Jun-04
4,552,884 MANOPLAX 07-Jan-05 722 days* 30-Dec-92 30-Dec-06
4,555,364 HECTOROL 01-Nov-04 1,601 days 21-Mar-09
4,559,174 TRILEPTAL 17-Dec-02 1,500 days 25-Jan-07
4,559,330 DIPENTUM 17-Dec-02 592 days 31-Jul-04
4,559,332 INSPRA 09-Apr-04 1,219 days 11-Aug-07
4,559,334 OMNICEF 17-Dec-02 1,601 days 06-May-07
4,562,073 ZOSYN 06-Jun-03 1,344 days 09-Feb-07
4,567,264 RANEXA 18-May-03 5 years 18-May-08
4,572,909 NORVASC 25-Feb-03 1,252 days 31-Jul-06
4,572,912 PRELAY/REZULIN 28-Aug-04 1,534 days 09-Nov-08
4,584,305 ERGAMISOL 22-Apr-03 423 days 18-Jun-04

4,585,597

ANTHELIOS SP 16-Jun-03 1,455 days (see note 6) 10-Jun-07
4,587,258 ALTACE 06-May-03 632 days 27-Jan-05
4,588,585 BETASERON 13-May-03 1,516 days 07-Jul-07
4,594,401 MENICON Z 27-Dec-04 1,200 days 10-Apr-08
4,598,089 XENICAL 18-Jun-04 5 years 18-Jun-09
4,599,353 XALATAN 08-Jul-03 1,116 days 28-Jul-06
4,602,017 LAMICTAL 22-Jul-03 5 years 22-Jul-08
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,604,463 CAMPTOSAR 05-Jul-04 1,141 days 20-Aug-07
4,619,921 ULTRAVATE 28-Oct-03 415 days 16-Dec-04
4,621,077 FOSOMAX 04-Nov-03 1,371 days 06-Aug-07
4,626,538 SONATA 23-Jun-03 1,810 days 06-Jun-08
4,628,098 PREVACID 29-Jul-05 1,381 days 10-May-95 10-May-09
4,631,278 CLINACOX 01-Aug-04 3 years 01-Aug-07
4,634,697 CEDAX 01-Oct-04 5 years 01-Oct-09
4,636,505 CASODEX 13-Jan-04 1,723 days 01-Oct-08
4,637,994 LIPOSORBER LA 15 01-Dec-03 5 years 01-Dec-08
4,639,436 GLYSET 27-Jan-04 5 years 27-Jan-09
4,650,807 SEMPREX-D 17-Mar-04 1,469 days 25-Mar-94 25-Mar-08
4,650,787 SANVAR 25-Apr-05 1 year (see note 5) 25-Apr-09
4,650,884 CELEXA 02-Aug-05 5 years 02-Aug-10
4,659,516 FASLODEX 01-Oct-04 1,166 days 11-Dec-07
4,659,716 CLARINEX 21-Apr-04 1,074 days 31-Mar-07
4,661,491 UROXATRAL 27-May-06 1,697 days 27-May-07
4,663,318 REMINYL 15-Jan-06 1,064 days 14-Dec-08
4,668,669 SYNERCID 10-Jan-06 1,333 days 04-Sep-09
4,670,444 BAYTRIL 09-Dec-03 3 years 09-Dec-06
4,681,893 LIPITOR 30-May-06 1,213 days 24-Sep-09
4,686,214 VEXOL 30-Oct-05 996 days 22-Jul-08
4,687,659 OMNISCAN INJECTION 13-Nov-04 786 days* 08-Jan-93 08-Jan-07
4,687,777 ACTOS 18-Jan-06 5 years 18-Jan-11
4,689,320 VITRAVENE INJECTION 15-Oct-04 939 days 12-May-07
4,689,338 ALDARA 25-Aug-04 5 years 25-Aug-09
4,689,339 ANTISEDAN 21-Nov-05 1,719 days 06-Aug-96 06-Aug-10
4,690,951 PAYLEAN 01-Sep-04 3 years 01-Sep-07
4,692,435 LOVENOX 04-Dec-01 1,116 days 24-Dec-04
4,695,578 ZOFRAN 25-Jan-05 ** 04-Jan-91 not applicable
4,695,590 ACTINEX CREAM 05-May-06 122 days* 04-Sep-92 04-Sep-06
4,695,623 INFERGEN 22-Sep-04 5 years 22-Sep-09
4,696,949 FARESTON 29-Sep-04 5 years 29-Sep-09
4,701,460 NUROMAX 20-Oct-04 137 days 06-Mar-05
4,702,253 META II MODEL 1204 CARDIAC PACING SYSTEM 15-Oct-05 ** 11-Oct-91 not applicable
4,703,035 GEREF 15-Sep-02 835 days 28-Dec-90 28-Dec-04
4,703,063 FLOMAX 27-Oct-04 5 years 27-Oct-09
4,703,752 LEA'S SHIELD 23-Aug-05 5 years 23-Aug-10
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,704,275 ROTASHIELD 26-Aug-05 5 years 26-Aug-10
4,708,956 LORABID 24-Nov-04 402 days 31-Dec-05
4,717,720 DIFFERIN 10-Apr-06 1,512 days 31-May-96 31-May-10
4,721,723 PAXIL 23-Oct-06 67 days* 29-Dec-92 29-Dec-06
4,730,000 OMNIFLOX 08-Mar-05 328 days 30-Jan-06
4,733,665 PALMAZ BALLOON-EXPANDABLE STENT 07-Nov-05 ** 27-Sep-91 not applicable
4,735,801 POULVAC ST vaccine 05-Apr-05 1,631 days 22-Sep-09
4,738,974 NEXIUM 19-Apr-05 865 days 01-Sep-07
4,739,101 LIPIDIL 27-Apr-07 248 days 31-Dec-93 31-Dec-07
4,745,177 IPRIVASK 17-May-05 5 years 17-May-10
4,746,680 MERIDIA 11-Jun-02 5 years 11-Jun-07
4,753,935 CELLCEPT 30-Jan-07 824 days 03-May-95 03-May-09
4,755,534 LAMISIL CREAM 05-Jul-05 543 days 30-Dec-06
4,757,006 ANTIHEMOPHILIC FACTOR CONCENTRATE
(RECOMBINANT)
12-Jul-05 516 days 10-Dec-06
4,757,057 NORMIFLO 12-Jul-05 5 years 12-Jul-10
4,758,579 PROTONIX 19-Jul-05 5 years 19-Jul-10
4,760,071 PROSCAR 26-Jul-05 328 days 19-Jun-06
4,761,237 EXTRANEAL 02-Aug-05 1468 days 09-Aug-09
4,761,418 MIVACRON 02-Aug-05 173 days 22-Jan-06
4,762,710 CERTIVA 16-Jun-06 1,807 days 28-May-11
4,762,856 SUPRANE 02-Feb-07 ** 18-Sep-92 not applicable
4,784,950 NOVOSEVEN 15-Nov-05 5 years 15-Nov-10
4,793,353 GENESIS NEUROSTIMULATION SYSTEM 27-Dec-05 323 days 15-Nov-06
4,795,751 ZAGAM 28-Oct-06 1,195 days 04-Feb-10
4,797,413 TRUSOPT 12-Dec-04 1,233 days 28-Apr-08
4,798,827 SYNERCID 21-May-07 1,770 days 25-Mar-12
4,801,577 ANTAGON 05-Feb-07 5 years 05-Feb-12
4,804,663 RISPERDAL 14-Feb-06 683 days* 29-Dec-93 29-Dec-07
4,804,680 AVIAX 21-Jul-07 237 days* 10-Mar-94 14-Mar-08
4,808,605 POSICOR 10-Nov-07 1,130 days 14-Dec-10
4,808,614 GEMZAR 28-Feb-06 1,537 days* 15-May-96 15-May-10
4,808,616 AROMASIN 07-Jul-06 1,729 days 01-Apr-11
4,812,561 CEDAX 01-Jul-07 903 days* 20-Dec-95 20-Dec-09
4,814,470 TAXOTERE 14-Jul-07 1,035 days* 14-May-96 14-May-10
4,816,456 COGNEX 01-Oct-06 343 days* 09-Sep-93 09-Sep-07
4,816,470 IMITREX 28-Mar-06 275 days 28-Dec-06
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,826,763 GLUCAGEN 02-May-06 1,421 days 23-Mar-10
4,826,868 ZUBRIN 29-May-06 1,404 days 02-Apr-10
4,830,010 MERETEK BREATH TEST 16-May-06 1,260 days 27-Oct-09
4,831,031 GEODON 02-Mar-07 5 years 02-Mar-12
4,834,757 LUMBAR I/F CAGE 30-May-06 1,777 days 11-Apr-11
4,836,217 ALLERGEN PATCH TEST
(THIN- LAYER RAPID USE EPICUTANEOUS
(T.R.U.E.) TEST)
06-Jun-06 899 days* 21-Nov-94 21-Nov-08
4,839,342 OPTIMMUNE 02-Sep-07 700 days* 02-Aug-95 02-Aug-09
4,839,350 SPECTRACEF 13-Jun-06 1,036 days 14-Apr-09
4,840,896 OVIDREL 20-Jun-06 1,044 days 29-Apr-09
4,844,882 ALBUNEX 29-Dec-07 220 days* 05-Aug-94 05-Aug-08
4,845,075 REGRANEX and Becaplermin Concentrate 04-Jul-06 1,578 days 29-Oct-10
4,847,265 PLAVIX 12-Feb-08 1,374 days 17-Nov-11
4,855,290 EVOXAC 08-Aug-06 1,118 days 30-Aug-09
4,859,692 ACCOLATE 22-Aug-06 1,496 days* 26-Sep-96 26-Sep-10
4,861,584 IVY BLOCK 29-Aug-06 1,458 days* 26-Aug-96 26-Aug-10
4,863,908 MONUROL 23-Feb-05 1,527 days 30-Apr-09
4,866,048 DOVONEX 12-Sep-06 473 days* 29-Dec-93 29-Dec-07
4,867,164 NEURO CYBERNETIC PROSTHESIS SYSTEM 19-Sep-06 1,761 days 16-Jul-97 16-Jul-11
4,868,112 REFACTO 19-Sep-06 1,258 days 28-Feb-10
4,868,908 VENTRITEX CADENCE MODEL V-100 TIERED THERAPY DEFIBRILLATOR SYSTEM 18-Oct-08 ** 30-Apr-93 not applicable
4,870,086 NAROPIN 24-Nov-06 1,400 days* 24-Sep-96 24-Sep-10
4,873,259 ZYFLO 10-Feb-07 1,398 days* 09-Dec-96 09-Dec-10
4,874,794 ABREVA 28-Apr-09 5 years 28-Apr-14
4,876,248 SKELID 24-Oct-06 1,194 days 30-Jan-10
4,879,288 SEROQUEL 20-Mar-07 1,651 days* 26-Sep-97 26-Sep-11
4,883,812 FLOLAN 03-Sep-02 1,347 days 12 May 06
4,885,243 CUBICIN 05-Dec-06 1,348 days 14-Aug-10
4,886,062 WIKTOR PRIME CORONARY STENT SYSTEM 19-Oct-07 1,347 days 27-Jun-97 27-Jun-11
4,886,808 KYTRIL 12-Dec-06 382 days 29-Dec-93 29-Dec-07
4,886,812 MIRAPEX 12-Dec-06 1,564 days 25-Mar-11
4,894,366 PROGRAF 16-Jan-07 448 days* 08-Apr-94 08-Apr-08
4,895,841 ARICEPT 20-Jun-08 888 days* 25-Nov-96 25-Nov-10
4,897,255 VERLUMA 30-Jan-07 1,298 days* 20-Aug-96 20-Aug-10
4,898,461 SILICONE AMO ARRAY MULTIFOCAL INTRAOCULAR LENS 01-Jun-07 1,557 days* 05-Sep-97 05-Sep-11
4,898,724 QUADRAMET 06-Feb-07 1,511 days 28-Mar-97 28-Mar-11
4,900,735 ZILMAX 11-Dec-07 5 years 11-Dec-12
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,902,683 EXCENEL 20-Feb-07 460 days 25-May-08
4,904,769 PRECOSE 27-Feb-07 922 days* 06-Sep-95 06-Sep-09
4,906,755 ANZEMET 06-Mar-07 1,579 days 02-Jul-11
4,910,214 PRECEDEX 15-Jul-08 5 years 15-Jul-13
4,911,920 BETAXON 27-Mar-07 565 days 12-Oct-08
4,911,932 VUSION 27-Mar-07 1 year (see note 3) 27-Mar-09
4,916,154 CYDECTIN 10-Apr-07 1,434 days 14-Mar-11
4,916,246 MULTIHANCE 10-Apr-07 5 years 10-Apr-12
4,919,140 ANDARA OFS System 14-Oct-08 1 year(s) (see note 5) 14-Oct-2010
4,927,814 BONIVA 09-Jul-07 1,713 days 17-Mar-12
4,927,855 NUVIGIL 22-May-07 1,066 days (see note 6) 22-Apr-10
4,933,456 TESLASCAN 12-Jun-07 1,628 days* 26-Nov-97 26-Nov-11
4,935,437 ARIMIDEX 10-Jun-08 565 days 27-Dec-95 27-Dec-09
4,935,507 OMNICEF 08-Aug-08 1,213 days* 04-Dec-97 04-Dec-11
4,937,078 SURPASS 26-Aug-08 1,748 days 09-Jun-13
4,937,234 NEUTERSOL 10-Aug-08 5 years 10-Aug-13
4,939,130 ZOMETA 13-Nov-07 1,755 days 02-Sep-12
4,941,093 EXCIMID UV200LA/SVS APEX (EXCIMER LASER SYSTEMS) 10-Jul-07 609 days* 10-Mar-95 10-Mar-09
4,943,569 MERREM 24-Jul-07 1,063 days* 21-Jun-96 21-Jun-10
4,943,639 KEPPRA 14-May-05 1,157 days See Note 4 14-Jul-08
4,947,840 INTEGRA 21-Aug-07 923 days* 01-Mar-96 01-Mar-10
4,948,807 EXELON 14-Aug-07 5 years 14-Aug-12
4,949,718 THERMA CHOICE 09-Sep-08 605 days 07-May-10
4,954,126 WALLSTENT Coronary Endoprosthesis 04-Sep-07 858 days 09-Jan-10
4,954,348 OXILAN 04-Sep-07 839 days 21-Nov-95 21-Dec-09
4,957,924 VALTREX 04-Aug-08 323 days* 23-Jun-95 23-Jun-09
4,958,632 KDR 401 & KDR 403 PACEMAKERS 25-Sep-08 537 days 15-Mar-09
4,959,366 TIKOSYN 25-Sep-07 5 years 25-Sep-12
4,961,740 RAY THREADED
FUSION CAGE
17-Oct-08 742 days* 29-Oct-96 29-Oct-10
4,963,489 DERMAGRAFT 16-Oct-07 5 years 16-Oct-12
4,966,891 XELODA 08-Nov-08 796 days 13-Jan-11
4,968,514 Diphenylmethane diisocynate 06-Nov-07 957 days 20-Jun-10
4,971,802 Mifamurtide 20-Nov-07 1 year(s) (see note 3) 20-Nov-2010
4,976,709 HYPERION LTK SYSTEM 11-Dec-07 1,644 days 11-Jun-12
4,977,138 ISTODAX 06-Jul-09 1 year(s) (see note 6) 06-Jul-11
4,978,655 ZERIT 18-Dec-07 189 days* 24-Jun-94 24-Jun-08
4,978,672 FEMARA 18-Dec-07 1,263 days 03-Jun-11
4,980,470 TEQUIN 25-Dec-07 721 days 15-Dec-09
4,990,517 AVELOX 30-Jun-09 901 days 18-Dec-11
4,996,335 LOTEMAX and ALREX 26-Feb-08 1,473 days* 09-Mar-98 09-Mar-12
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
4,997,841 AMERGE 12-Aug-08 694 days 07-Jul-10
5,002,953 AVANDIA 30-Aug-08 1,113 days 17-Sept-11
5,004,758 HYCAMTIN 02-Apr-08 786 days* 28-May-96 28-May-10
5,006,528 ABILIFY 20-Oct-09 5 years 20-Oct-14
5,006,530 BAYCOL 17-Jan-09 890 days* 26-Jun-97 26-Jun-11
5,008,256 TRITEC 17-Jul-09 387 days* 08-Aug-96 08-Aug-10
5,010,090 GABITRIL 23-Apr-08 1,255 days* 30-Sep-97 30-Sep-11
5,015,247 BAK INTERBODY FUSION SYSTEM 13-Jun-08 829 days* 20-Sep-96 20-Sep-10
5,019,583 ULTIVA 15-Feb-09 512 days* 12-Jul-96 12-Jul-10
5,021,458 MENTAX 04-Jun-08 866 days* 18-Oct-96 18-Oct-10
5,023,269 CYMBALTA 11-Jun-08 5 years 11-Jun-13
5,034,230 ALAMAST 23-Dec-08 740 days 02-Jan-11
5,034,394 ZIAGEN 26-Jun-09 905 days 18-Dec-11
5,041,126 COOK GRII CORONARY STENT 13-Mar-07 340 days 16-Feb-08
5,045,302 MYOVIEW 06-Oct-08 491 days* 09-Feb-96 09-Feb-10
5,045,552 ACIPHEX 03-Sep-08 1,708 days 08-May-13
5,047,407 EPIVIR 08-Feb-09 282 days* 17-Nov-95 17-Nov-09
5,053,407 LEVAQUIN 01-Oct-08 810 days* 20-Dec-96 20-Dec-10
5,061,703 NAMENDA 11-Apr-10 5 years 11-Apr-15
5,070,877 ADENOSCAN 10-Dec-08 159 days* 18-May-95 18-May-09
5,075,222 KINERET 24-Dec-08 5 years 24-Dec-13
5,075,445 DENAVIR 24-Dec-08 639 days* 24-Sep-96 24-Sep-10
5,079,262 LEVULAN KERASTICK 28-Jul-09 1,525 days 30-Sep-13
5,089,480 DECTOMAX 18-Feb-09 527 days* 30-Jul-96 30-Jul-10
5,089,509 TAZORAC 18-Feb-09 845 days* 13-Jun-97 13-Jun-11
5,095,030 VISUDYNE 24-Apr-07 1,599 days 09-Sep-11
5,096,890 ENABLEX 13-Mar-10 5 years 13-Mar-15
5,100,899 RAPAMUNE 06-Jun-09 1,492 days 07-Jul-13
5,101,013 LANTUS 31-Mar-09 977 days 03-Dec-11
5,114,923 NATRECOR 19-May-09 5 years 19-May-14
5,116,863 PATANOL 26-May-09 571 days* 18-Dec-96 18-Dec-10
5,124,316 GEM 21S 23-Jun-09 989 days 08-Mar-12
5,125,926 HEART LASER CO2 TRANSMYOCARDIAL REVASCULARIZATION
SYSTEM
24-Sep-10 696 days* 20-Aug-98 20-Aug-12
5,135,943 ERTACZO 04-Aug-09 1,761 days 31-May-14
5,142,051 VISTIDE 25-Aug-09 305 days* 26-Jun-96 26-Jun-10
5,143,724 SYNVISC 09-Jul-10 395 days* 08-Aug-97 08-Aug-11
5,145,863 PHOTOFRIN 12-Jun-07 916 days 14-Dec-09
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
5,153,222 REMODULIN 06-Oct-09 5 years 06-Oct-14
5,155,268 CORVERT 13-Oct-09 76 days* 28-Dec-95 28-Dec-09
5,156,957 GONAL-F 08-May-07 1,605 days* 29-Sep-97 29-Sep-11
5,158,952 INVEGA 27-Oct-09 895 days 09-Apr-12
5,162,504 PROSTASCINT 10-Nov-09 352 days* 28-Oct-96 28-Oct-10
5,164,194 ASTELIN 17-Nov-09 349 days* 01-Nov-96 01-Nov-10
5,164,402 TROVAN 17-Nov-09 761 days* 18-Dec-97 18-Dec-11
5,171,569 BENEFIX 15-Dec-09 423 days* 11-Feb-97 11-Feb-11
5,180,668 REFLUDAN 19-Jan-10 777 days 06-Mar-12
5,192,319 PHAKIC INTRAOCULAR LENS 20-May-11 1,491 days 19-Jun-15
5,192,808 ANIPRYL 31-Aug-10 272 days* 30-May-97 30-May-11
5,194,247 SOLAGE 16-Mar-10 1,365 days 10-Dec-99 10-Dec-13
5,196,444 ATACAND 18-Apr-11 413 days* 04-Jun-98
5,198,533 CETROTIDE 17-Jul-07 1,195 days 24-Oct-10
5,199,939 GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM 06-Apr-10 921 days 13-Oct-12
5,202,333 ALOXI 13-Apr-10 5 years 13-Apr-15
5,206,244 BARACLUDE 18-Oct-10 1,587 days 21-Feb-15
5,214,052 ACOVA 25-May-10 1,497 days 30-Jun-14
5,215,895 NEUMEGA 01-Jun-10 542 days* 25-Nov-97 25-Nov-11
5,221,763 RESCULA 22-Jun-10 754 days 15-Jul-12
5,223,256 RETAVASE 29-Jun-10 124 days* 30-Oct-96 30-Oct-10
5,234,404 GENESA 10-Aug-10 398 days* 12-Sep-97 12-Sep-11
5,236,952 TASMAR 17-Aug-10 530 days 29-Jan-98 29-Jan-12
5,246,925 ZEMPAR 21-Sep-10 574 days* 17-Apr-98 17-Apr-12
5,250,534 VIAGRA 18-Jun-11 283 days* 27-Mar-98 27-Mar-12
5,250,542 ENTEREG 29-Mar-11 5 years 29-Mar-16
5,254,556 INVEGA SUSTENNA 27-Oct-09 1 year (see note 3) 27-Oct-10
5,258,494 OP-1 Implant 02-Nov-10 1,525 days 05-Jan-15
5,260,291 TEMODAR 09-Nov-10 1,006 days* 11-Aug-99 11-Aug-13
5,270,317 AVAPRO 20-Mar-11 194 days* 30-Sep-98 30-Sep-11
5,275,813 FEL-O-VAX 04-Jan-11 5 years 04-Jan-16
5,279,811 NEUROLITE 18-Mar-08 250 days* 23-Nov-94 23-Nov-08
5,284,858 AMITIZA 08-Feb-11 1,252 days 14-Jul-14
5,288,726 EFFIENT 08-Sep-12 1,679 days 14-Apr-17
5,292,740 TRACLEER 09-Jun-12 1,259 days 20-Nov-01 20-Nov-15
5,292,756 AGGRASTAT 08-Mar-11 433 days* 14-May-98 14-May-12
5,298,520 MAXALT 28-Jan-12 153 days* 29-Jun-98 29-Jun-12
5,317,016 DORIBAX 14-Aug-12 1,025 days 05-Jun-15
5,344,452 ARTEFILL 06-Sept-11 5 years 06-Sep-16
5,344,932 ALIMTA 06-Sep-11 1,783 days 24-Jul-16
5,354,330 ATS OPEN PIVOT
BILEAFLET HEART VALVE
16-Sep-13 928 days 01-Apr-16
5,356,804 FABRAZYME 18-Oct-11 1,440 days 27-Sep-15
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
5,360,800 LOTRONEX 02-Feb-10 1,076 days 13-Jan-13
5,360,817 RELENZA 01-Nov-11 633 days 26-Jul-13
5,360,897 PREVNAR 16-Jun-04 1,086 days 06-Jan-07
5,362,755 XOPENEX 08-Nov-11 503 days* 25-Mar-99 25-Mar-13
5,364,646 VETMEDIN 15-Nov-11 1,393 days 08-Sep-15
5,364,842 PRIALT 30-Dec-11 5 years 30-Dec-16
5,368,840 LUMENHANCE 29-Nov-11 20 days* 19-Dec-97 19-Dec-11
5,378,703 AZOPT 09-Apr-10 723 days* 01-Apr-98 01-Apr-12
5,382,518 ELITEK 17-Jan-12 1,638 days* 12-Jul-02 12-Jul-16
5,382,600 DETROL 17-Jan-12 68 days 25-Mar-98 25-Mar-12
5,385,732 TNKASE 31-Jan-12 853 days* 02-Jun-00

02-Jun-14

5,387,603 RAPAFLO 18-Dec-13 5 years 12-Dec-18
5,405,363 SENTINEL MODEL 2000/2010 11-Apr-12 130 days 19-Aug-12
5,407,914 SURFAXIN 11-Nov-09 1 year (see note 5) 17-Nov-10
5,418,226 RAPLON 14-Apr-13 126 days* 18-Aug-13
5,420,319 ELOXATIN 07-Apr-13 1,220 days* 09-Aug-02 09-Aug-16
5,424,286 BYETTA 24-May-13 1,287 days 01-Dec-16
5,424,295 ARRANON 13-Jun-12 5 years 13-Jun-17
5,441,745 DAUNOXOME 28-May-08 238 days 21-Jan-09
5,444,106 CEE-ON Edge Intraocular Lens 22-Aug-12 956 days 05-Aug-01 05-Apr-15
5,446,194 COMTAN 29-Sep-12 416 days 19-Nov-13
5,451,233 XIENCE V 29-Oct-08 777 days 15-Dec-10
5,453,446 AZILECT 07-Feb-12 5 years 07-Feb-17
5,464,864 FROVA 07-Nov-12 1,096 days* 08-Nov-01 08-Nov-15
5,470,932 ACRYSOF 18-Oct-13 815 days 11-Jan-16
5,478,820 INVANZ 02-Feb-13 1,022 days* 21-Nov-01 21-Nov-15
5,480,668 NEOTAME 07-Nov-12 973 days* 09-Jul-02 08-Jul-15
5,482,934 ONMARIS 09-Jan-13 1,749 days 24-Oct-17
5,494,903 TYGACIL 13-Aug-12 1,335 days 09-Apr-16
5,510,106 FEL-O-VAX LvK/FIV 04-Jan-11 1,348 days 13-Sep-14
5,510,353 ZELNORM 23-Apr-13 1,188 days* 24-Jul-02 24-Jul-16
5,514,650 CANCIDAS 16-Mar-13 681 days* 26-Jan-01 26-Jan-15
5,514,713 PROFENDER 07-May-13 814 days 30-Jul-15
5,521,184 GLEEVEC 28-May-13 586 days 04-Jan-15
5,521,207 DERAMAXX 30-Nov-13 883 days 01-May-16
5,523,221 GYNECARE INTERGEL 02-Jul-13 867 days* 16-Nov-01 16-Nov-15
5,527,521 DEFINITY 05-Apr-11 1,419 days 22-Feb-15
5,545,644 RELPAX 13-Aug-13 1,231 days* 26-Dec-02 26-Dec-16
5,547,853 AMEVIVE 20-Aug-13 1,259 days* 30-Jan-03 30-Jan-17
5,559,111 TEKTURNA 04-Apr-15 1,204 days 21-Jul-18
5,563,146 CYPHER 28-Apr-12 557 days 06-Nov-13
5,565,447 AXERT 15-Oct-13 569 days 07-May-01 07-May-15
5,565,467 AVODART 15-Oct-13 766 days* 20-Nov-01 20-Nov-15
5,567,817 VFEND 22-Oct-13 945 days 24-May-02 24-May-16
5,565,473 SINGULAIR 30-Nov-10 430 days 03-Feb-12
5,571,182 MACROPLASTIQUE IMPLANTS 02-Nov-10 1,664 days 24-May-15
5,595,760 SOMATULINE DEPOT 08-Mar-15 5 years 08-Mar-20
5,616,599 BENICAR 01-Apr-14 755 days* 25-Apr-02 25-Apr-16
5,618,913 NOVOLOG 08-Apr-14 61 days* 07-Jun-00 07-Jun-14
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
5,624,411 ENDEAVOR 29-Apr-14 973 days 27-Dec-16
5,626,851 ROTATEQ 06-May-14 1,750 days 19-Feb-19
5,635,485 KETEK 21-Apr-15 1,076 days* 01-Apr-04 01-Apr-18
5,635,517 REVLIMID 24-Jun-16 1,167 days 04-Oct-19
5,639,443 IMAGENT 17-Jun-14 714 days* 31-May-02 31-May-16
5,639,639 LUVERIS 20-Jun-06 5 years 20-Jun-11
5,656,667 OMACOR 12-Aug-14 1,476 days 27-Aug-18
5,658,590 STRATTERA 11-Jan-15 685 days* 26-Nov-02 26-Nov-16
5,661,136 CLOLAR 26-Aug-14 1,237 days 14-Jan-18
5,661,151 NOXAFIL 26-Aug-14 1,788 days 19-Jul-19
5,667,767 ONYX LES 27 Jul-15 1,269 days 16-Jan-19
5,667,787 DAPTACEL 16-Sep-14 606 days* 14-May-02 14-May-16
5,681,814 INCRELEX 28-Oct-14 1,056 days 18-Sep-17
5,681,818 IPLEX 28-Oct-14 1,656 days 11-May-19
5,686,411 SYMLIN 11-Nov-14 1,586 days* 16-Mar-05 16-Mar-19
5,688,819 LUMIGAN 21-Sep-12 698 days 20-Aug-14
5,691,336 EMEND 04-Mar-14 5 years 04-Mar-19
5,716,981 TAXUS Express 10-Feb-15 488 days 12-Jun-16
5,719,147 EMEND 29-Jun-12 1,022 days 17-Apr-15
5,723,606 VAPRISOL 03-Mar-15 1,748 days 15-Dec-19
5,747,498 TARCEVA 06-Jun-15 1,251 days 08-Nov-18
5,750,497 LEVEMIR 12-May-15 1,497 days* 16-Jun-05 16-Jun-19
5,770,599 IRESSA 26-Apr-16 374 days* 05-May-03 05-May-17
5,776,456 ZEVALIN 07-Jul-15 227 days* 19-Feb-02 19-Feb-16
5,776,944 FACTIVE 15-Jun-15 659 days* 04-Apr-03 04-Apr-17
5,780,454 VELCADE 28-Oct-14 918 days 03-May-17
5,795,911 VEREGEN 10-Apr-17 1,300 days* 31-Oct-06 31-Oct-20
5,820,870 GARDACIL 13-Oct-15 1,199 days 24-Jan-19
5,827,937 RESTAYLANE 17-Jul-15 879 days* 12-Dec-03 12-Dec-17
5,840,299 TYSABRI 25-Jan-14 1,188 days* 27-Apr-17
5,843,901 PLENAXIS 01-Dec-15 725 days* 25-Nov-03 25-Nov-17
5,849,535 SOMAVERT 21-Sep-15 551 days* 25-Mar-03 25-Mar-17
5,849,911 REYATAZ 09-Apr-17 72 days* 20-Jun-03 20-Jun-17
5,851,795 ORENCIA 01-Dec-15 1,413 days* 14-Oct-19
5,852,195 APTIVUS 22-Dec-15 1,278 days 22-Jun-05 22-Jun-19
5,859,006 CIALIS 12-Jan-16 679 days* 21-Nov-03 21-Nov-17
5,876,746 ORTHO-EVRA 07-Jun-15 166 days* 20-Nov-01 20-Nov-15
5,886,036 KALETRA 29-Dec-12 325 days 19-Nov-13
5,889,052 TRAVATAN 03-Aug-13 486 days 02-Dec-14
5,914,331 EMTRIVA 29-Sep-15 642 days 02-Jul-17
5,932,211 ELAPRASE 03-Aug-16 1,126 days 03-Sep-19
Patent No. Tradename of
Approved Product
Original Exp.
Date (Note 1)
Extension Approval Date
(If Relevant) (Note 2)
Extended Expiration Date
5,951,974 PEG-INTRON 10-Nov-13 435 days* 19-Jan-01 19-Jan-15
5,965,138 NAHVAX 12-Oct-16 1,539 days 29-Dec-20
5,965,525 ERAXIS 12-Oct-16 1,223 days* 17-Feb-06 17-Feb-20
5,968,976 FOSRENOL 19-Mar-16 951 days* 26-Oct-04 26-Oct-18
5,981,576 PREVICOX 09-Oct-16 651 days* 21-Jul-04 21-Jul-18
5,984,967 InFuse Bone
Graft/LT-Cage Lumbar Tapered Fusion
27-Mar-15 464 days* 02-Jul-02 02-Jul-16
6,001,876 LYRICA (NDA No. 21-723) 16-Jul-17 533 days* 30-Dec-04 30-Dec-18
6,011,068 SENSIPAR 14-Dec-16 449 days 08-Mar-18
6,017,927 VESICARE 27-Dec-15 1,058 days* 19-Nov-04 19-Nov-18
6,034,239 ROZEREM 06-Mar-17 868 days* 22-Jul-05 22-Jul-19
6,039,931 EOVIST 21-Mar-17 1,698 days 13-Nov-21
6,051,698 MACUGEN 17-Oct-12 944 days 19-May-15
6,054,297 AVASTIN 25-Apr-17 307 days* 26-Feb-04 26-Feb-18
6,083,953 VALCYTE 28-Jul-14 244 days* 29-Mar-01 29-Mar-15
6,090,382 HUMIRA 09-Feb-16 326 days* 21-Dec-02 31-Dec-16
6,107,458 MYCAMINE 29-Sep-15 1,265 days* 16-Mar-05 16-Mar-19
6,114,319 DUREZOL 12-May-18 371 days 18-May-19
6,118,045 MYOZYME 29-Jul-16 750 days 18-Aug-18
6,133,418 FUZEON 07-Jun-13 528 days 17-Nov-14
6,197,819 LYRICA (NDA No. 21-446) 06-Mar-18 300 days* 30-Dec-04 30-Dec-18
6,217,866 ERBITUX 17-Jan-17 391 days 12-Feb-18
6,222,038 CERENIA INJECTABLE SOLUTION 21-Apr-15 966 days 12-Dec-17
6,235,030 X-STOP Interspinous Process Decompression System 02-Jan-17 1,053 days* 21-Nov-05 21-Nov-19
6,235,883 VECTIBIX 05-May-17 1,069 days* 08-Apr-20
6,248,775 PREZISTA 25-Aug-12 718 days 13-Aug-14
6,255,320 CERENIA TABLETS 08-May-20 266 days* 29-Jan-07 29-Jan-21
6,267,958 XOLAIR 14-Mar-16 463 days* 20-Jun-03 20-Jun-17
6,306,141 TALENT 23-Oct-18 1,270 days 15-Apr-22
6,309,402 S8 Over the Wire System 19-Dec-14 413 days 04-Feb-16
6,355,245 SOLIRIS 12-Mar-19 735 days* 16-Mar-07 16-Mar-21
6,407,213 LUCENTIS 18-Jun-19 378 days* 30-Jun-06 30-Jun-20
6,410,550 CHANTIX 13-Nov-18 544 days* 10-May-06 10-May-20
6,420,536 DRAXXIN 29-May-18 360 days* 24-May-05 24-May-19
6,444,673 LUNESTA 16-Jan-12 760 days 14-Feb-14
6,465,504 EXJADE 24-Jun-17 650 days 05-Apr-19
6,569,837 TYZEKA 10-Aug-19 442 days* 25-Oct-06 25-Oct-20
6,583,272 MIRCERA 26-Aug-20 445 days* 14-Nov-07 14-Nov-21
6,596,746 SPRYCEL 13-Apr-20 76 days* 28-Jun-20
6,667,314 SELZENTRY 25-May-21 73 days* 06-Aug-07 06-Aug-21
6,713,485 TYKERB 08-Jan-19 630 days 29-Sep-20
6,740,669 BANZEL 17-Aug-20 819 days 14-Nov-22
6,835,809 NPLATE 22-Oct-19 820 days 19-Jan-22
6,884,434 NEUPRO 18-Mar-19 743 days 30-Mar-21
7,037,917 INTELENCE 19-Nov-05 404 days 13-Dec-20
*
Shows recalculated extension due to § 156(c)(3).
**
Previously granted extension under § 156 superceded by § 154 term.
***
Extension runs from the approval date, not the original expiration date. 35 U.S.C. § 156(d)(5)(E)(ii).
Note 1
The original expiration date assumes that all maintenance fees are paid and that there is no premature expiration of the patent.
Note 2
An approval date is normally only shown where the extension has been limited by the 14-year limit of 35 U.S.C. § 156(c)(3).
Note 3
Interim extension under 35 USC 156(e)(2).
Note 4
Terminal disclaimer filed after patent term extension was granted.
Note 5 Interim extension under 35 USC 156(d)(5).
Note 6 Interim extensions under 156(d)(5) and 156(e)(2).