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Serving 500+ biopharmaceutical companies globally:

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Generated: July 27, 2017

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Treprostinil diolamine - Generic Drug Details

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What are the generic drug sources for treprostinil diolamine and what is the scope of treprostinil diolamine patent protection?

Treprostinil diolamine
is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has sixty-three patent family members in eleven countries.

There are fifteen drug master file entries for treprostinil diolamine. Two suppliers are listed for this compound.

Summary for Generic Name: treprostinil diolamine

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list15
Suppliers / Packagers: see list2
Bulk Api Vendors: see list1
Clinical Trials: see list72
Patent Applications: see list7
Drug Prices:see low prices
DailyMed Link:treprostinil diolamine at DailyMed

Pharmacology for Ingredient: treprostinil diolamine

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;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► Subscribe ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: treprostinil diolamine

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;ORAL203496-002Dec 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
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Non-Orange Book Patents for Generic Ingredient: treprostinil diolamine

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
8,536,363Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,624,156Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,242,305Process to prepare treprostinil, the active ingredient in remodulin► Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► 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 Ingredient: treprostinil diolamine

Country Document Number Estimated Expiration
Denmark1025083► Subscribe
European Patent Office1025083► Subscribe
European Patent Office1628654► Subscribe
Japan2014114317► 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 500+ biopharmaceutical companies globally:

Covington
Chinese Patent Office
Express Scripts
Baxter
Colorcon
Cantor Fitzgerald
Teva
Boehringer Ingelheim
Cerilliant
US Department of Justice

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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