epoprostenol sodium - Profile

What are the generic sources for epoprostenol sodium and what is the scope of freedom to operate?

Epoprostenol sodium is the generic ingredient in three branded drugs marketed by Gland, Meitheal, Mylan, Sun Pharm, Glaxosmithkline Llc, and Actelion, and is included in six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Epoprostenol sodium has nineteen patent family members in fifteen countries.

Summary for epoprostenol sodium

International Patents:	19
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	6
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
Gland	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	219237-002	Dec 29, 2025	AP2	RX	No	No
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-001	Apr 23, 2008		RX	No	Yes
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-002	Apr 23, 2008		RX	No	Yes
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913-001	Jun 12, 2024	AP2	RX	No	No
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913-002	Jun 12, 2024	AP2	RX	No	No

Expired US Patents for epoprostenol sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995

International Patents for epoprostenol sodium

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1993557	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)
Russian Federation	2008135701	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ
South Korea	20090004867	NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF
Hungary	E026166
Japan	2009525344
Slovenia	1993557