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 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.
Summary for OSPHENA
| International Patents: | 94 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 2 |
| Patent Applications: | 364 |
| 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 |
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 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavailablity of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for enhancing the bioavalability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavalability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Method for enhancing the bioavailability of ospemifene
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Mexico | PA03000378 | METODO PARA EL TRATAMIENTO DE DESORDENES CLIMATERICOS EN MUJERES DURANTE Y DESPUES DE LA MENOPAUSIA. (METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE.) | ⤷ Try a Trial |
| Australia | 5844901 | ⤷ Try a Trial | |
| Poland | 202654 | ⤷ Try a Trial | |
| China | 1953741 | Solid formulations of ospemifene | ⤷ Try a Trial |
| Hong Kong | 1056694 | ⤷ Try a Trial | |
| Slovakia | 287096 | ⤷ Try a Trial | |
| Hungary | 229361 | METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OSPHENA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1713458 | 92736 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 20150115 |
| 1713458 | 28/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119 |
| 1713458 | PA2015023,C1713458 | Lithuania | ⤷ Try a Trial | 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 |
| 1713458 | 2015/031 | Ireland | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115 |
| 1713458 | C300742 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115 |
| 1713458 | 15C0041 | France | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115 |
| 1713458 | SPC/GB15/035 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/14/978/001 20150115; UK 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.
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