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Last Updated: December 7, 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 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 ⤷  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 ⤷  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
>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 ⤷  Try it Free 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 28/2015 Austria ⤷  Try it Free PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458 1590030-1 Sweden ⤷  Try it Free PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119
1713458 C20150029 00165 Estonia ⤷  Try it Free PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458 CA 2015 00031 Denmark ⤷  Try it Free PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: 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:

Express Scripts
McKesson
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.