Ospemifene - Generic Drug Details
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What are the generic 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 seven 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. Two suppliers are listed for this compound.
Summary for ospemifene
International Patents: | 94 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 10 |
Patent Applications: | 691 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ospemifene |
What excipients (inactive ingredients) are in ospemifene? | ospemifene excipients list |
DailyMed Link: | ospemifene at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ospemifene
Generic Entry Date for ospemifene*:
Constraining patent/regulatory exclusivity:
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 ospemifene
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital Clinic of Barcelona | Phase 4 |
Emory University | Phase 4 |
Sue Goldstein | Phase 4 |
Pharmacology for ospemifene
Drug Class | Estrogen Agonist/Antagonist |
Mechanism of Action | Selective Estrogen Receptor Modulators |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | 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 ospemifene
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 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 |
---|---|---|---|
Canada | 2554695 | FORMULATIONS SOLIDES D'OSPEMIFENE (SOLID FORMULATIONS OF OSPEMIFENE) | ⤷ Try a Trial |
Poland | 359506 | ⤷ Try a Trial | |
Japan | 2004504345 | ⤷ Try a Trial | |
European Patent Office | 2286806 | Formulations solides d'ospemifene (Solid formulations of ospemifene) | ⤷ Try a Trial |
South Africa | 200300342 | Method for the treatment of climacteric disorders in women during or after the menopause. | ⤷ Try a Trial |
China | 1446085 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ospemifene
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1713458 | 1590030-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119 |
1713458 | 28/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119 |
1713458 | 216 5010-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119 |
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 | 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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