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Last Updated: May 18, 2021

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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 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 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 VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 AP2 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 AP2 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-001 Jan 15, 2021 AP2 RX No No   Get Started Free   Get Started Free   Get Started Free
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-001 Apr 23, 2008 AP1 RX No No   Get Started Free   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 AP1 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 020444-001 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Get Started Free   Get Started Free
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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