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Last Updated: October 23, 2021

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OSPEMIFENE - Generic Drug Details

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

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 C20150029 00165 Estonia ⤷  Try it Free PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458 92736 Luxembourg ⤷  Try it Free PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 20150115
1713458 2015/031 Ireland ⤷  Try it Free PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458 216 5010-2015 Slovakia ⤷  Try it Free PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
1713458 132016000023047 Italy ⤷  Try it Free PRODUCT NAME: OSPEMIFENE IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(SENSHIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/978/001-002, 20150115
1713458 15C0041 France ⤷  Try it Free PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Dow
Colorcon
Merck
Baxter

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