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Last Updated: March 29, 2023

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 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 Y 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
Japan 5575351 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005077350 See Plans and Pricing
Israel 153823 USE OF OSPEMIFENE FOR THE MANUFACTURE OF A PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF CLIMACTERIC DISORDERS DURING OR AFTER THE MENOPAUSE See Plans and Pricing
Portugal 1713458 See Plans and Pricing
Brazil PI0507661 m├ętodo para aumentar a biodisponibilidade de um composto terapeuticamente ativo, e, uso de um composto ativo See Plans and Pricing
Japan 2004504345 See Plans and Pricing
Spain 2241819 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 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 92736 Luxembourg See Plans and Pricing PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 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 15C0041 France See Plans and Pricing PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458 216 5010-2015 Slovakia See Plans and Pricing PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
1713458 C20150029 00165 Estonia See Plans and Pricing PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
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
>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.