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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
AstraZeneca
Deloitte
US Army
Novartis
Federal Trade Commission
Healthtrust
Mallinckrodt
McKinsey

Generated: February 22, 2018

DrugPatentWatch Database Preview

OSPHENA Drug Profile

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When do Osphena patents expire, and what generic alternatives are available?

Osphena is a drug marketed by Duchesnay and is included in one NDA. There are eight patents protecting this drug.

This drug has ninety patent family members in thirty-one countries.

The generic ingredient in OSPHENA is ospemifene. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.
Summary for OSPHENA
Drug patent expirations by year for OSPHENA
Pharmacology for OSPHENA

US Patents and Regulatory Information for OSPHENA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Non-Orange Book US Patents for OSPHENA

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
6,984,665 Methods for the inhibition of atrophy or for treatment or prevention of atrophy-related symptoms in women ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for OSPHENA

Supplementary Protection Certificates for OSPHENA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015023 Lithuania ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
2015 00031 Denmark ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
6 5010-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
2015 00031 Denmark ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; REG. NO/DATE: EU/1/14/978/001-002 20150115
0150029 00165 Estonia ➤ Try a Free Trial PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
00742 Netherlands ➤ Try a Free Trial PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
C0041 France ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
15/031 Ireland ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
2015023,C1713458 Lithuania ➤ Try a Free Trial PRODUCT NAME: OSPEMIFENAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
UBS
Cerilliant
Julphar
QuintilesIMS
Cipla
Daiichi Sankyo
Harvard Business School

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