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Last Updated: February 24, 2020

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Estradiol; norgestimate - Generic Drug Details

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What are the generic drug sources for estradiol; norgestimate and what is the scope of freedom to operate?

Estradiol; norgestimate is the generic ingredient in two branded drugs marketed by Barr and Teva Womens, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; norgestimate has eighteen patent family members in sixteen countries.

There are seventy-five drug master file entries for estradiol; norgestimate. One supplier is listed for this compound.

Summary for estradiol; norgestimate
Recent Clinical Trials for estradiol; norgestimate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Benha UniversityPhase 2/Phase 3
Gilead SciencesPhase 1
Lexicon PharmaceuticalsPhase 1

See all estradiol; norgestimate clinical trials

Recent Litigation for estradiol; norgestimate

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 estradiol; norgestimate litigation

Paragraph IV (Patent) Challenges for ESTRADIOL; NORGESTIMATE
Tradename Dosage Ingredient NDA Submissiondate
PREFEST TABLET;ORAL estradiol; norgestimate 021040

US Patents and Regulatory Information for estradiol; norgestimate

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
Barr ESTRADIOL AND NORGESTIMATE estradiol; norgestimate TABLET;ORAL 076812-001 Apr 29, 2005 RX No Yes   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 estradiol; norgestimate

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for estradiol; norgestimate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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