Last Updated: June 18, 2026

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. 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 23^rd, 2008.

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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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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