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Serving leading biopharmaceutical companies globally:

Express Scripts
Novartis
AstraZeneca
Covington
QuintilesIMS
Healthtrust
Johnson and Johnson
Chubb
McKesson
US Department of Justice

Generated: February 19, 2018

DrugPatentWatch Database Preview

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 thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-five patent family members in eight countries.

There are sixteen drug master file entries for treprostinil diolamine. Two suppliers are listed for this compound.
Summary for treprostinil diolamine
Pharmacology for treprostinil diolamine
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for treprostinil diolamine

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;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for treprostinil diolamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,384,978 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
9,199,908 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
8,242,305 Process to prepare treprostinil, the active ingredient in remodulin ➤ Sign Up
9,624,156 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
8,748,657 Process to prepare treprostinil ➤ Sign Up
9,156,786 Process to prepare treprostinil, the active ingredient in remodulin.RTM. ➤ Sign Up
9,878,972 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
8,232,316 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
8,536,363 Compounds and methods for delivery of prostacyclin analogs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for treprostinil diolamine

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Boehringer Ingelheim
Accenture
Moodys
US Army
AstraZeneca
Teva
UBS

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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