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Last Updated: March 3, 2024

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 Hong Kong, Sun Pharm, 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. Three 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 EffectVasodilation
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
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 AP1 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hong Kong EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-002 Jan 15, 2021 AP2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hong Kong EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-001 Apr 23, 2008 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

International Patents for epoprostenol sodium

Country Patent Number Title Estimated Expiration
Canada 2868998 NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF) ⤷  Try a Trial
Russian Federation 2423130 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (EPOPROSTENOL-CONTAINING COMPOSITION AND METHOD OF ITS OBTAINING) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007092343 ⤷  Try a Trial
Hungary E026166 ⤷  Try a Trial
Denmark 1993557 ⤷  Try a Trial
Russian Federation 2008135701 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.