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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fuji
McKesson
US Department of Justice
Moodys
Medtronic
Harvard Business School
Chubb
Dow

Generated: May 20, 2018

DrugPatentWatch Database Preview

Estradiol; norgestimate - Generic Drug Details

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What are the generic sources for estradiol; norgestimate and what is the scope of estradiol; norgestimate patent protection?

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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Barr ESTRADIOL AND NORGESTIMATE estradiol; norgestimate TABLET;ORAL 076812-001 Apr 29, 2005 RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for estradiol; norgestimate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,078,394 Low dose estrogen interrupted hormone replacement therapy ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for estradiol; norgestimate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2016 00016 Denmark ➤ Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2015000093 Germany ➤ Sign Up PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0002 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Chubb
Moodys
Boehringer Ingelheim
QuintilesIMS
Colorcon
Queensland Health
Accenture
Mallinckrodt

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