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Last Updated: May 6, 2021

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EPOPROSTENOL SODIUM Drug Profile

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Which patents cover Epoprostenol Sodium, and what generic alternatives are available?

Epoprostenol Sodium is a drug marketed by Sun Pharm and Teva Pharms Usa and is included in two NDAs.

The generic ingredient in EPOPROSTENOL SODIUM is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epoprostenol Sodium

A generic version of EPOPROSTENOL SODIUM was approved as epoprostenol sodium by TEVA PHARMS USA on April 23rd, 2008.

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Drug patent expirations by year for EPOPROSTENOL SODIUM
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
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-001 Jan 15, 2021 AP2 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP1 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-002 Jan 15, 2021 AP2 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-001 Apr 23, 2008 AP1 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
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Boehringer Ingelheim
Moodys
AstraZeneca
Dow

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