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EPOPROSTENOL SODIUM Drug Profile
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When do Epoprostenol Sodium patents expire, and what generic alternatives are available?
Epoprostenol Sodium is a drug marketed by Teva Pharms Usa and is included in one NDA.
The generic ingredient in EPOPROSTENOL SODIUM is epoprostenol sodium. There are seven drug master file entries for this compound. Three 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 TEVA PHARMS USA on April 23rd, 2008.
Summary for EPOPROSTENOL SODIUM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 7 |
| Patent Applications: | 653 |
| Formulation / Manufacturing: | see details |
| 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
Paragraph IV (Patent) Challenges for EPOPROSTENOL SODIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELETRI | INJECTABLE;INJECTION | epoprostenol sodium | 022260 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-001 | Apr 23, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-002 | Apr 23, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
