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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Cipla
Covington
Farmers Insurance
AstraZeneca
Accenture
Deloitte
Daiichi Sankyo
Teva

Generated: January 24, 2018

DrugPatentWatch Database Preview

Orenitram Drug Profile

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When do Orenitram patents expire, 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-nine patent family members in eleven 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:69
US Patents:14
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 203496-002 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
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
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives ➤ Subscribe
9,624,156 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,536,363 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,242,305 Process to prepare treprostinil, the active ingredient in remodulin ➤ Subscribe
9,156,786 Process to prepare treprostinil, the active ingredient in remodulin.RTM. ➤ Subscribe
9,199,908 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
6,528,688 Prostacyclin derivatives ➤ Subscribe
7,384,978 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,232,316 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,748,657 Process to prepare treprostinil ➤ Subscribe
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 leading biopharmaceutical companies globally:

Novartis
Accenture
US Army
Harvard Business School
Fish and Richardson
Express Scripts
Moodys
Covington
Argus Health

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