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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Teva
Farmers Insurance
Moodys
Merck
Mallinckrodt
Novartis
Accenture
Baxter
Medtronic

Generated: December 11, 2017

DrugPatentWatch Database Preview

ORENITRAM Drug Profile

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Which patents cover Orenitram, and what generic 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

Drug patent expirations by year for ORENITRAM

Pharmacology for ORENITRAM

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► 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 TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-001Dec 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
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
8,242,305Process to prepare treprostinil, the active ingredient in remodulin► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
8,748,657Process to prepare treprostinil► Subscribe
9,199,908Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,232,316Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,536,363Compounds 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
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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
Canada2526534► Subscribe
South Korea101544246► Subscribe
Canada2710205► Subscribe
European Patent Office2010189► Subscribe
Japan5841554► Subscribe
Spain2399200► Subscribe
European Patent Office2252570► Subscribe
China101780092► Subscribe
World Intellectual Property Organization (WIPO)2007127216► Subscribe
Portugal1025083► 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:

Mallinckrodt
Fish and Richardson
Dow
Daiichi Sankyo
Chinese Patent Office
Baxter
UBS
US Department of Justice
Chubb
Argus Health

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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