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Last Updated: January 27, 2023

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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for ospemifene

Country Patent Number Title Estimated Expiration
Russian Federation 2011112362 ТВЕРДЫЕ ПРЕПАРАТИВНЫЕ ФОРМЫ ОСПЕМИФЕНА See Plans and Pricing
Austria 506054 See Plans and Pricing
Austria 387910 See Plans and Pricing
European Patent Office 2286806 Formulations solides d'ospemifene (Solid formulations of ospemifene) See Plans and Pricing
South Korea 20030048378 See Plans and Pricing
Cyprus 1111014 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ospemifene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 PA2015023,C1713458 Lithuania See Plans and Pricing 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 CR 2015 00031 Denmark See Plans and Pricing PRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458 C300742 Netherlands See Plans and Pricing PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458 132016000023047 Italy See Plans and Pricing 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 PA2015023 Lithuania See Plans and Pricing PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458 122015000048 Germany See Plans and Pricing PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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