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Last Updated: May 25, 2020

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PREFEST Drug Profile


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Which patents cover Prefest, and when can generic versions of Prefest launch?

Prefest is a drug marketed by Teva Womens and is included in one NDA. There are two patents protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.

US ANDA Litigation and Generic Entry Outlook for Prefest

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PREFEST
Recent Litigation for PREFEST

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC.2010-03-09
TEVA WOMEN'S HEALTH, INC. v. LUPIN, LTD.2010-02-03

See all PREFEST litigation

Synonyms for PREFEST
(8R,9S,10R,13S,14S)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
6533-00-2
CAS-6533-00-2
CHEMBL2107797
dl-Norgestrel
DSSTox_CID_27477
DSSTox_GSID_47477
DSSTox_RID_82374
NCGC00256735-01
norgestrel
Q7051185
SCHEMBL37118
Tox21_303623
WWYNJERNGUHSAO-CULCCENASA-N
Paragraph IV (Patent) Challenges for PREFEST
Tradename Dosage Ingredient NDA Submissiondate
PREFEST TABLET;ORAL estradiol; norgestimate 021040

US Patents and Regulatory Information for PREFEST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREFEST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PREFEST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
0398460 12/2004 Austria   Start Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Colorcon
Johnson and Johnson
McKesson
AstraZeneca

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