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Last Updated: May 19, 2022

OSPHENA Drug Patent Profile


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Which patents cover Osphena, and when can generic versions of Osphena launch?

Osphena is a drug marketed by Duchesnay and is included in one NDA. There are eight 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. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.

DrugPatentWatch® Generic Entry Outlook for Osphena

Osphena was eligible for patent challenges on February 26, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 9, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for OSPHENA
Drug Prices for OSPHENA

See drug prices for OSPHENA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for OSPHENA
Generic Entry Date for OSPHENA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OSPHENA

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

SponsorPhase
Emory UniversityPhase 4
Sue GoldsteinPhase 4

See all OSPHENA clinical trials

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 nineteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OSPHENA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OSPHENA

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

Method for enhancing the bioavailablity of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for enhancing the bioavalability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavalability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 alleviation of dyspareunia in women
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Method for enhancing the bioavailability of ospemifene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

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

FDA Regulatory Exclusivity protecting OSPHENA

TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE
Exclusivity Expiration: 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
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

International Patents for OSPHENA

When does loss-of-exclusivity occur for OSPHENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05215174
Estimated Expiration: See Plans and Pricing

Austria

Patent: 6054
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0507897
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54695
Estimated Expiration: See Plans and Pricing

China

Patent: 53741
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11689
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 18288
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 18288
Estimated Expiration: See Plans and Pricing

Patent: 86806
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005027540
Estimated Expiration: See Plans and Pricing

Japan

Patent: 93203
Estimated Expiration: See Plans and Pricing

Patent: 07523210
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06009546
Estimated Expiration: See Plans and Pricing

Norway

Patent: 1573
Estimated Expiration: See Plans and Pricing

Patent: 064262
Estimated Expiration: See Plans and Pricing

Poland

Patent: 18288
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 18288
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 23113
Estimated Expiration: See Plans and Pricing

Patent: 75624
Estimated Expiration: See Plans and Pricing

Patent: 06133902
Estimated Expiration: See Plans and Pricing

Patent: 11112362
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 18288
Estimated Expiration: See Plans and Pricing

Spain

Patent: 64970
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OSPHENA around the world.

Country Patent Number Title Estimated Expiration
Brazil PI0507661 método para aumentar a biodisponibilidade de um composto terapeuticamente ativo, e, uso de um composto ativo See Plans and Pricing
Slovenia 1713458 See Plans and Pricing
Estonia 200300031 See Plans and Pricing
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) See Plans and Pricing
Japan 2013060445 METHOD FOR TREATMENT OF CLIMACTERIC DISORDER IN WOMAN DURING OR AFTER MENOPAUSE See Plans and Pricing
Hungary 229361 METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE See Plans and Pricing
>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 See Plans and Pricing
1713458 92736 Luxembourg See Plans and Pricing PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 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 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 28/2015 Austria See Plans and Pricing PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Johnson and Johnson
Moodys
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Colorcon

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.