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Last Updated: November 4, 2024

OSPEMIFENE Drug Patent Profile


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Which patents cover Ospemifene, and what generic alternatives are available?

Ospemifene is a drug marketed by Hetero Labs Ltd V and is included in one NDA.

The generic ingredient in OSPEMIFENE is ospemifene. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ospemifene

A generic version of OSPEMIFENE was approved as ospemifene by HETERO LABS LTD V on February 13th, 2024.

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Drug patent expirations by year for OSPEMIFENE
Recent Clinical Trials for OSPEMIFENE

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

See all OSPEMIFENE clinical trials

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
Hetero Labs Ltd V OSPEMIFENE ospemifene TABLET;ORAL 215574-001 Feb 13, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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