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 fourteen 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 eight 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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Summary for ORENITRAM
| International Patents: | 59 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 7 |
| Patent Applications: | 73 |
| Drug Prices: | Drug price information for ORENITRAM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ORENITRAM |
| What excipients (inactive ingredients) are in ORENITRAM? | ORENITRAM excipients list |
| DailyMed Link: | ORENITRAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ORENITRAM
*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
| Sponsor | Phase |
|---|---|
| Lung Biotechnology PBC | Phase 4 |
| United Therapeutics | Phase 4 |
| Bial - Portela C S.A. | Phase 1 |
Pharmacology for ORENITRAM
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
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 fifteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORENITRAM is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and methods for delivery of prostacyclin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and methods for delivery of prostacyclin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid formulations of prostacyclin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and methods for delivery of prostacyclin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Osmotic drug delivery system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and methods for delivery of prostacyclin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
Osmotic drug delivery system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting ORENITRAM
INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Exclusivity Expiration: ⤷ Sign Up
| 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 | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-003 | Dec 20, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-004 | 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 | 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 |
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 | 203496-003 | 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 |
| 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 |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-005 | Oct 7, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >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: 32520
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 49243
Patent: DISPOSITIF D'ADMINISTRATION D'UN MEDICAMENT OSMOTIQUE (AN OSMOTIC DRUG DELIVERY SYSTEM)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1466384
Patent: Osmotic drug delivery system comprising release enhancing agent
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10189
Patent: DISPOSITIF OSMOTIQUE D'ADMINISTRATION D'UN MÉDICAMENT COMPRENANT UN PROMOTEUR DE LA LIBÉRATION (OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT)
Estimated Expiration: ⤷ Sign Up
Patent: 68556
Patent: Dispositif osmotique d'administration d'un médicament (An osmotic drug delivery system)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 70209
Estimated Expiration: ⤷ Sign Up
Patent: 41554
Estimated Expiration: ⤷ Sign Up
Patent: 42371
Estimated Expiration: ⤷ Sign Up
Patent: 09535337
Estimated Expiration: ⤷ Sign Up
Patent: 13139468
Patent: OSMOTIC PRESSURE DRUG DELIVERY SYSTEM
Estimated Expiration: ⤷ Sign Up
Patent: 16026155
Patent: 浸透圧薬物送達システム (OSMOTIC DRUG DELIVERY SYSTEM)
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1555455
Estimated Expiration: ⤷ Sign Up
Patent: 090038392
Patent: OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT
Estimated Expiration: ⤷ Sign Up
Patent: 140075805
Patent: OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 77387
Estimated Expiration: ⤷ Sign Up
Patent: 99200
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Spain | 2198760 | ⤷ Sign Up | |
| Denmark | 299089 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2005007081 | ⤷ Sign Up | |
| China | 1264819 | ⤷ Sign Up | |
| European Patent Office | 2427054 | COMPOSITIONS SOLIDES À BASE D'ANALOGUES DE PROSTACYCLINE (SOLID FORMULATIONS OF PROSTACYCLIN ANALOGS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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