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Last Updated: August 7, 2020

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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 Teva Pharms Usa, Glaxosmithkline Llc, and Actelion Pharms Ltd, and is included in three 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 NDA Submissiondate
VELETRI INJECTABLE;INJECTION epoprostenol sodium 022260 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
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP RX No No   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

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

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Harvard Business School

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