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Serving leading biopharmaceutical companies globally:

US Department of Justice
Dow
Federal Trade Commission
UBS
Healthtrust
McKesson
Fish and Richardson
QuintilesIMS
Colorcon
Deloitte

Generated: February 21, 2018

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 thirteen patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-five patent family members in eight countries.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are sixteen 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
International Patents:55
US Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 2
Clinical Trials: 4
Patent Applications: 153
Drug Prices:see details
DailyMed Link:ORENITRAM at DailyMed
Drug patent expirations by year for ORENITRAM
Pharmacology for ORENITRAM
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for ORENITRAM

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 203496-005 Oct 7, 2016 RX Yes No ➤ 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 203496-003 Dec 20, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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 203496-004 Dec 20, 2013 RX Yes Yes ➤ 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 ➤ 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 203496-003 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 ➤ 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 ORENITRAM

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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Paragraph IV (Patent) Challenges for ORENITRAM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 0.25 mg and 1 mg ➤ Subscribe 5/19/2016
➤ Subscribe Extended-release Tablets 2.5 mg ➤ Subscribe 12/24/2015

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

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International Patents for ORENITRAM

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Dow
Johnson and Johnson
Moodys
Chinese Patent Office
Express Scripts
Covington
Cantor Fitzgerald
Boehringer Ingelheim

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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