Epoprostenol sodium - Generic Drug Details

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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 Meitheal, Mylan, Sun Pharm, Glaxosmithkline Llc, and Actelion, and is included in five 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.

There are seven drug master file entries for epoprostenol sodium. Four suppliers are listed for this compound.

Summary for epoprostenol sodium

International Patents:	19
US Patents:	2
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	1,477
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epoprostenol sodium
What excipients (inactive ingredients) are in epoprostenol sodium?	epoprostenol sodium excipients list
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

See all epoprostenol sodium clinical trials

Pharmacology for epoprostenol sodium

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for epoprostenol sodium

Antihypertensive Agents
Platelet Aggregation Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for epoprostenol sodium

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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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Glossary

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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
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	210473-002	Jan 15, 2021	AP2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	AP1	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-002	Apr 23, 2008	AP1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913-001	Jun 12, 2024	AP2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913-002	Jun 12, 2024	AP2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for epoprostenol sodium

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

International Patents for epoprostenol sodium

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Country	Patent Number	Title	Estimated Expiration
Denmark	1993557		⤷ Sign Up
Cyprus	1117128		⤷ Sign Up
Canada	2868998	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)	⤷ Sign Up
South Korea	20090004867	NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF	⤷ Sign Up
Russian Federation	2008135701	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ	⤷ Sign Up
Portugal	1993557		⤷ Sign Up
Japan	2009525344		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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