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Last Updated: November 29, 2022

Epoprostenol sodium - Generic Drug Details


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What are the generic drug 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 Sun Pharm, Teva Pharms Usa, Glaxosmithkline Llc, and Actelion, and is included in four 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.

Recent Clinical Trials for epoprostenol sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 4
ActelionPhase 4
United TherapeuticsPhase 4

See all epoprostenol sodium clinical trials

Pharmacology for epoprostenol sodium
Drug ClassProstacycline Vasodilator
Physiological Effect Vasodilation
Medical Subject Heading (MeSH) Categories 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
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-001 Jan 15, 2021 AP2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-001 Apr 23, 2008 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 AP2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 AP1 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for epoprostenol sodium

Country Patent Number Title Estimated Expiration
Japan 2009525344 See Plans and Pricing
South Korea 20090004867 NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF See Plans and Pricing
Brazil PI0707488 método para a produção de uma composição de epoprostenol, composição farmacêutica e solução estável See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007092343 See Plans and Pricing
Portugal 1993557 See Plans and Pricing
Cyprus 1117128 See Plans and Pricing
European Patent Office 1993557 NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.