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Last Updated: May 27, 2022

ORENITRAM Drug Patent 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 three Paragraph IV challenges.

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

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.

DrugPatentWatch® Generic Entry Outlook for Orenitram

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 11, 2031. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ORENITRAM
Drug Prices for ORENITRAM

See drug prices for ORENITRAM

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORENITRAM
Generic Entry Date for ORENITRAM*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ORENITRAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lung Biotechnology PBCPhase 4
United TherapeuticsPhase 4
Bial - Portela C S.A.Phase 1

See all ORENITRAM clinical trials

Paragraph IV (Patent) Challenges for ORENITRAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORENITRAM Extended-release Tablets treprostinil diolamine 0.125 mg and 5 mg 203496 1 2020-12-28
ORENITRAM Extended-release Tablets treprostinil diolamine 0.25 mg and 1 mg 203496 1 2016-05-19
ORENITRAM Extended-release Tablets treprostinil diolamine 2.5 mg 203496 1 2015-12-24

US Patents and Regulatory Information for ORENITRAM

ORENITRAM is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORENITRAM is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ORENITRAM

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid formulations of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Osmotic drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

Osmotic drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).

Osmotic drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ORENITRAM

INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for ORENITRAM

When does loss-of-exclusivity occur for ORENITRAM?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 2520
Estimated Expiration: See Plans and Pricing

Canada

Patent: 49243
Estimated Expiration: See Plans and Pricing

China

Patent: 1466384
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 10189
Estimated Expiration: See Plans and Pricing

Patent: 68556
Estimated Expiration: See Plans and Pricing

Japan

Patent: 70209
Estimated Expiration: See Plans and Pricing

Patent: 41554
Estimated Expiration: See Plans and Pricing

Patent: 42371
Estimated Expiration: See Plans and Pricing

Patent: 09535337
Estimated Expiration: See Plans and Pricing

Patent: 13139468
Estimated Expiration: See Plans and Pricing

Patent: 16026155
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1555455
Estimated Expiration: See Plans and Pricing

Patent: 090038392
Estimated Expiration: See Plans and Pricing

Patent: 140075805
Estimated Expiration: See Plans and Pricing

Spain

Patent: 77387
Estimated Expiration: See Plans and Pricing

Patent: 99200
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORENITRAM around the world.

Country Patent Number Title Estimated Expiration
Canada 2307163 PROCEDE DE SYNTHESE STEREOSELECTIVE DE DERIVES DE LA PROSTACYCLINE (PROCESS FOR STEREOSELECTIVE SYNTHESIS OF PROSTACYCLIN DERIVATIVES) See Plans and Pricing
South Korea 20060021862 COMPOUNDS AND METHODS FOR DELIVERY OF PROSTACYCLIN ANALOGS See Plans and Pricing
European Patent Office 2792353 Polymorphe du sel de diéthanolamine de Treprostinil (Polymorph of Treprostinil diethanolamine salt) See Plans and Pricing
European Patent Office 2427054 COMPOSITIONS SOLIDES À BASE D'ANALOGUES DE PROSTACYCLINE (SOLID FORMULATIONS OF PROSTACYCLIN ANALOGS) See Plans and Pricing
China 103274926 An improved process to prepare treprostinil, the active ingredient in Remodulin See Plans and Pricing
China 101903324 Process to prepare treprostinil, the active ingredient in Remodulin See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Dow
Harvard Business School
Express Scripts
Merck

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 verification 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.