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 and Sun Pharm and is included in two NDAs.
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 MEITHEAL on April 23rd, 2008.
Summary for EPOPROSTENOL SODIUM
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 210473-002 | Jan 15, 2021 | AP2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-002 | Apr 23, 2008 | AP1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 210473-001 | Jan 15, 2021 | AP2 | RX | No | 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 |
