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Last Updated: November 8, 2024

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osphena Drug Patent Profile


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

Osphena is a drug marketed by Duchesnay and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in thirty-one countries.

The generic ingredient in OSPHENA 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 Osphena

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

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Drug patent expirations by year for osphena
Drug Prices for osphena

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Recent Clinical Trials for osphena

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Emory UniversityPhase 4
Sue GoldsteinPhase 4

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Pharmacology for osphena
Paragraph IV (Patent) Challenges for OSPHENA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OSPHENA Tablets ospemifene 60 mg 203505 1 2020-12-29

US Patents and Regulatory Information for osphena

osphena is protected by eighteen US patents.

Patents protecting osphena

Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailablity of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailablity of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE

Method for enhancing the bioavailablity of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE

Solid formulations of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method for enhancing the bioavalability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavalability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavalability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF 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 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 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
>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 osphena

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 osphena

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 osphena

See the table below for patents covering osphena around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1713458 PROCEDE D'AMELIORATION DE LA BIODISPONIBILITE D'OSPEMIFENE (METHOD FOR ENHANCING THE BIOAVAILABILITY OF OSPEMIFENE) ⤷  Sign Up
Norway 20064262 ⤷  Sign Up
Brazil PI0507897 formulação de droga sólida ⤷  Sign Up
Russian Federation 2268035 СПОСОБ ЛЕЧЕНИЯ КЛИМАКТЕРИЧЕСКИХ РАССТРОЙСТВ У ЖЕНЩИН ВО ВРЕМЯ ИЛИ ПОСЛЕ МЕНОПАУЗЫ (METHOD FOR TREATING CLIMACTERIC DISORDERS IN WOMEN EITHER DURING OR AFTER MENOPAUSE) ⤷  Sign Up
Slovenia 1718288 ⤷  Sign Up
Slovenia 1305014 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for osphena

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 576 Finland ⤷  Sign Up
1713458 CA 2015 00031 Denmark ⤷  Sign Up PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458 216 5010-2015 Slovakia ⤷  Sign Up PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
1713458 28/2015 Austria ⤷  Sign Up PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458 C20150029 00165 Estonia ⤷  Sign Up PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458 PA2015023 Lithuania ⤷  Sign Up 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.