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Last Updated: November 4, 2024

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 two branded drugs marketed by Hetero Labs Ltd V and Duchesnay, and is included in two NDAs. 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.

Summary for ospemifene
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
Hetero Labs Ltd V OSPEMIFENE ospemifene TABLET;ORAL 215574-001 Feb 13, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  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

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 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
>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
Norway 329954 ⤷  Sign Up
Lithuania PA2015023 ⤷  Sign Up
Slovenia 1713458 ⤷  Sign Up
China 1953741 Solid formulations of ospemifene ⤷  Sign Up
South Africa 200300342 Method for the treatment of climacteric disorders in women during or after the menopause. ⤷  Sign Up
Spain 2302177 ⤷  Sign Up
Portugal 1305014 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ospemifene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 122015000048 Germany ⤷  Sign Up PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458 576 Finland ⤷  Sign Up
1713458 C20150029 00165 Estonia ⤷  Sign Up PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458 CA 2015 00031 Denmark ⤷  Sign Up PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458 132016000023047 Italy ⤷  Sign Up 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 2015/031 Ireland ⤷  Sign Up PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458 PA2015023,C1713458 Lithuania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.