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Serving leading biopharmaceutical companies globally:

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Healthtrust
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Accenture
Moodys
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Treprostinil - Generic Drug Details

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What are the generic sources for treprostinil and what is the scope of treprostinil freedom to operate?

Treprostinil
is the generic ingredient in three branded drugs marketed by United Therap and is included in three NDAs. There are twenty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil has ninety-four patent family members in twelve countries.

There are fifteen drug master file entries for treprostinil. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for treprostinil

Pharmacology for treprostinil

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

Tentative approvals for TREPROSTINIL

Applicant Application No. Strength Dosage Form
u► Subscribe1MG/MLINJECTABLE;INJECTION
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 TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo► 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► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: treprostinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002► Subscribe► Subscribe
United TherapTYVASOtreprostinilSOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002► Subscribe► Subscribe
United TherapREMODULINtreprostinilINJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002► Subscribe► Subscribe
United TherapTYVASOtreprostinilSOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: treprostinil

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
8,252,839Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,278,901Compounds and methods for delivery of prostacyclin analogs► Subscribe
7,544,713Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,765,813Use of treprostinil to treat and prevent ischemic lesions► Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
9,624,156Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,410,169Compounds and methods for delivery of prostacyclin analogs► Subscribe
7,384,978Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,327,031Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same► 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

Country Document Number Estimated Expiration
European Patent Office1354588► Subscribe
South Korea101614465► Subscribe
South Korea20100105852► Subscribe
Japan5190200► Subscribe
Japan2016047850► Subscribe
Portugal1161234► Subscribe
South Korea101390579► Subscribe
World Intellectual Property Organization (WIPO)0054758► Subscribe
South Korea20160048222► Subscribe
Canada2710205► 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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Serving leading biopharmaceutical companies globally:

Accenture
Healthtrust
Daiichi Sankyo
McKinsey
Cerilliant
Julphar
Medtronic
Citi
Covington
Fuji

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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