EPOPROSTENOL SODIUM Drug Patent Profile
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When do Epoprostenol Sodium patents expire, and what generic alternatives are available?
Epoprostenol Sodium is a drug marketed by Meitheal, Mylan, and Sun Pharm. and is included in three NDAs.
The generic ingredient in EPOPROSTENOL SODIUM is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epoprostenol Sodium
A generic version of EPOPROSTENOL SODIUM was approved as epoprostenol sodium by MEITHEAL on April 23rd, 2008.
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Questions you can ask:
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Summary for EPOPROSTENOL SODIUM
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 7 |
| Patent Applications: | 978 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPOPROSTENOL SODIUM |
| DailyMed Link: | EPOPROSTENOL SODIUM at DailyMed |
Recent Clinical Trials for EPOPROSTENOL SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 4 |
| Actelion | Phase 4 |
| United Therapeutics | Phase 4 |
Pharmacology for EPOPROSTENOL SODIUM
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for EPOPROSTENOL SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for EPOPROSTENOL SODIUM
Paragraph IV (Patent) Challenges for EPOPROSTENOL SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VELETRI | Injection | epoprostenol sodium | 0. 5m/vial and 1.5 mg/vial | 022260 | 1 | 2017-03-31 |
US Patents and Regulatory Information for EPOPROSTENOL SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-001 | Apr 23, 2008 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 213913-002 | Jun 12, 2024 | AP2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-002 | Apr 23, 2008 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 213913-001 | Jun 12, 2024 | AP2 | 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 |
