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Epoprostenol sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for epoprostenol sodium?

Epoprostenol sodium is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actelion Pharms Ltd, and Teva Pharms Usa, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirteen patent family members in twelve countries.

There are six drug master file entries for epoprostenol sodium. Three suppliers are listed for this compound.

Summary for Generic Name: epoprostenol sodium

Tradenames:3
Patents:3
Applicants:3
NDAs:3
Drug Master File Entries: see list6
Suppliers / Packagers: see list3
Bulk Api Vendors: see list19
Clinical Trials: see list929
Patent Applications: see list486
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:epoprostenol sodium at DailyMed

Pharmacology for Ingredient: epoprostenol sodium

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
EPOPROSTENOL SODIUM
epoprostenol sodium
INJECTABLE;INJECTION078396-001Apr 23, 2008RXNoNo► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 1995RXYesYes► Subscribe► Subscribe
Teva Pharms Usa
EPOPROSTENOL SODIUM
epoprostenol sodium
INJECTABLE;INJECTION078396-002Apr 23, 2008RXNoNo► Subscribe► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-001Sep 20, 1995RXYesYes► Subscribe► Subscribe
Actelion Pharms Ltd
VELETRI
epoprostenol sodium
INJECTABLE;INJECTION022260-002Jun 28, 2012RXYesNo8,598,227► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: epoprostenol sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 19954,883,812► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-001Sep 20, 19954,335,139► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 19954,335,139► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 19954,338,325► Subscribe
Glaxosmithkline Llc
FLOLAN
epoprostenol sodium
INJECTABLE;INJECTION020444-002Sep 20, 19954,539,333► Subscribe
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International Patent Family for Ingredient: epoprostenol sodium

Country Document Number Estimated Expiration
Japan5415771► Subscribe
Russian Federation2423130► Subscribe
European Patent Office1993557► Subscribe
BrazilPI0707488► Subscribe
Japan2009525344► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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