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 Gland, Meitheal, Mylan, and Sun Pharm. and is included in four NDAs.
The generic ingredient in EPOPROSTENOL SODIUM is epoprostenol sodium. There are seven drug master file entries for this compound. Five 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:
- What is the 5 year forecast for EPOPROSTENOL SODIUM?
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- What is Average Wholesale Price for EPOPROSTENOL SODIUM?
Summary for EPOPROSTENOL SODIUM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 219237-001 | Dec 29, 2025 | AP2 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 210473-001 | Jan 15, 2021 | AP2 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-002 | Apr 23, 2008 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sun Pharm | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 210473-002 | Jan 15, 2021 | AP2 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Gland | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 219237-002 | Dec 29, 2025 | AP2 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-001 | Apr 23, 2008 | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 213913-002 | Jun 12, 2024 | AP2 | 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 |
