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Last Updated: October 26, 2021

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Ospemifene - Generic Drug Details

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What are the generic sources for ospemifene and what is the scope of patent protection?

Ospemifene is the generic ingredient in one branded drug marketed by Duchesnay and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ospemifene has ninety-four patent family members in thirty-one countries.

There are six drug master file entries for ospemifene. One supplier is listed for this compound.

Recent Clinical Trials for ospemifene

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

SponsorPhase
Hospital Clinic of BarcelonaPhase 4
Emory UniversityPhase 4
Sue GoldsteinPhase 4

See all ospemifene clinical trials

Pharmacology for ospemifene
Paragraph IV (Patent) Challenges for OSPEMIFENE
Tradename Dosage Ingredient NDA Submissiondate
OSPHENA TABLET;ORAL ospemifene 203505

US Patents and Regulatory Information for ospemifene

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ospemifene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 PA2015023,C1713458 Lithuania ⤷  Free Forever 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
1713458 122015000048 Germany ⤷  Free Forever Trial PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458 C300742 Netherlands ⤷  Free Forever Trial PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458 15C0041 France ⤷  Free Forever Trial PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458 1590030-1 Sweden ⤷  Free Forever Trial PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
McKesson
Colorcon
Boehringer Ingelheim
McKinsey

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