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Last Updated: March 19, 2024

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 seven 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. Two suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ospemifene
Generic Entry Date for ospemifene*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Strength NDA ANDAs Submitted Submissiondate
OSPHENA Tablets ospemifene 60 mg 203505 1 2020-12-29

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

Expired US Patents for ospemifene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ospemifene

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Shionogi B.V. Senshio ospemifene EMEA/H/C/002780
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Authorised no no no 2015-01-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ospemifene

Country Patent Number Title Estimated Expiration
Canada 2554695 FORMULATIONS SOLIDES D'OSPEMIFENE (SOLID FORMULATIONS OF OSPEMIFENE) ⤷  Try a Trial
Poland 359506 ⤷  Try a Trial
Japan 2004504345 ⤷  Try a Trial
European Patent Office 2286806 Formulations solides d'ospemifene (Solid formulations of ospemifene) ⤷  Try a Trial
South Africa 200300342 Method for the treatment of climacteric disorders in women during or after the menopause. ⤷  Try a Trial
China 1446085 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ospemifene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 1590030-1 Sweden ⤷  Try a Trial PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119
1713458 28/2015 Austria ⤷  Try a Trial PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458 216 5010-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
1713458 2015/031 Ireland ⤷  Try a Trial PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458 C300742 Netherlands ⤷  Try a Trial PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458 SPC/GB15/035 United Kingdom ⤷  Try a Trial PRODUCT NAME: OSPEMIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/14/978/001 20150115; UK EU/1/14/978/002 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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