OSPEMIFENE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Ospemifene, and what generic alternatives are available?
Ospemifene is a drug marketed by Hetero Labs Ltd V and is included in one NDA.
The generic ingredient in OSPEMIFENE 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 Ospemifene
A generic version of OSPEMIFENE was approved as ospemifene by HETERO LABS LTD V on February 13th, 2024.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for OSPEMIFENE?
- What are the global sales for OSPEMIFENE?
- What is Average Wholesale Price for OSPEMIFENE?
Summary for OSPEMIFENE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 10 |
Patent Applications: | 301 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSPEMIFENE |
DailyMed Link: | OSPEMIFENE at DailyMed |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for OSPEMIFENE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | OSPEMIFENE | ospemifene | TABLET;ORAL | 215574-001 | Feb 13, 2024 | AB | RX | No | No | ⤷ 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 |
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 |