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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Citi
Teva
McKesson
Fuji
Harvard Business School
Medtronic
Moodys
US Department of Justice
Boehringer Ingelheim
Dow

Generated: November 18, 2017

DrugPatentWatch Database Preview

Orenitram Drug Profile

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What is the patent landscape for Orenitram, and what generic Orenitram alternatives are available?

Orenitram is a drug marketed by United Therap and is included in one NDA. There are fourteen patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in eleven countries.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil diolamine profile page.

Summary for Orenitram

Pharmacology for Orenitram

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: ORENITRAM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ORENITRAM

Drugname Dosage Strength RLD Submissiondate
treprostinilExtended-release Tablets0.25 mg and 1 mgOrenitram5/19/2016
treprostinilExtended-release Tablets2.5 mgOrenitram12/24/2015

Non-Orange Book Patents for Tradename: ORENITRAM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,624,156Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,748,657Process to prepare treprostinil► Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
8,242,305Process to prepare treprostinil, the active ingredient in remodulin► Subscribe
8,232,316Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
9,199,908Compounds and methods for delivery of prostacyclin analogs► Subscribe
7,384,978Compounds and methods for delivery of prostacyclin analogs► Subscribe
6,528,688 Prostacyclin derivatives► Subscribe
8,536,363Compounds and methods for delivery of prostacyclin analogs► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ORENITRAM

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9921830► Subscribe
Canada2736406► Subscribe
Portugal1025083► Subscribe
South Korea20160048222► Subscribe
Japan2012162539► Subscribe
China100558351► Subscribe
Canada2307163► Subscribe
China1264819► Subscribe
Spain2622471► Subscribe
European Patent Office2010189► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Novartis
Citi
Deloitte
Dow
Federal Trade Commission
Fuji
Chinese Patent Office
QuintilesIMS

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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