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
Summary for OSPHENA
International Patents: | 94 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 2 |
Patent Applications: | 460 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OSPHENA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSPHENA |
What excipients (inactive ingredients) are in OSPHENA? | OSPHENA excipients list |
DailyMed Link: | OSPHENA at DailyMed |


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
Sponsor | Phase |
---|---|
Emory University | Phase 4 |
Sue Goldstein | Phase 4 |
Pharmacology for OSPHENA
Drug Class | Estrogen Agonist/Antagonist |
Mechanism of Action | Selective Estrogen Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |