Orenitram Patent Expiration

Orenitram is a drug owned by United Therapeutics Corp. It is protected by 16 US drug patents filed from 2013 to 2023. Out of these, 9 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 11, 2031. Details of Orenitram's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6765117 Process for stereoselective synthesis of prostacyclin derivatives
Oct, 2017

(6 years ago)

Expired
US9050311 Compounds and methods for delivery of prostacyclin analogs
May, 2024

(a month ago)

Expired
US7417070 Compounds and methods for delivery of prostacyclin analogs
Jul, 2026

(2 years from now)

Active
US8497393 Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin®
Dec, 2028

(4 years from now)

Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5153222 Method of treating pulmonary hypertension with benzidine prostaglandins
Oct, 2014

(9 years ago)

Expired
US9278901 Compounds and methods for delivery of prostacyclin analogs
May, 2024

(a month ago)

Expired
US9422223 Compounds and methods for delivery of prostacyclin analogs
May, 2024

(a month ago)

Expired
US8252839 Compounds and methods for delivery of prostacyclin analogs
May, 2024

(a month ago)

Expired
US7544713 Compounds and methods for delivery of prostacyclin analogs
Jul, 2024

(4 days ago)

Expired
US9393203 Osmotic drug delivery system
Apr, 2026

(1 year, 9 months from now)

Active
US8410169 Compounds and methods for delivery of prostacyclin analogs
Feb, 2030

(5 years from now)

Active
US8349892 Solid formulations of prostacyclin analogs
Jan, 2031

(6 years from now)

Active
US8747897 Osmotic drug delivery system
Aug, 2031

(7 years from now)

Active


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Orenitram and ongoing litigations to help you estimate the early arrival of Orenitram generic.

Orenitram's Litigations

Orenitram has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 02, 2015, against patent number US8497393. The petitioner SteadyMed Ltd., challenged the validity or infringement of this patent, with United Therapeutics Corporation as the respondent. Click below to track the latest information on how companies are challenging Orenitram's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9593066 March, 2020 Terminated-Denied United Therapeutics Corp. Liquidia Technologies, Inc.
US9604901 March, 2020 FWD Entered United Therapeutics Corp. Liquidia Technolgies, Inc.
US8497393 October, 2015 FWD Entered United Therapeutics Corporation SteadyMed Ltd.


FDA has granted some exclusivities to Orenitram. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orenitram, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Orenitram.

Exclusivity Information

Orenitram holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Orenitram's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Dec 20, 2016
New Dosing Schedule(D-156) Jan 28, 2019
New Dosing Schedule(D-157) Jan 28, 2019
Orphan Drug Exclusivity(ODE-308) Dec 20, 2020
New Indication(I-820) Oct 18, 2022
Orphan Drug Exclusivity(ODE-272) Oct 18, 2026

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Several oppositions have been filed on Orenitram's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Orenitram's generic, the next section provides detailed information on ongoing and past EP oppositions related to Orenitram patents.

Orenitram's oppositions filed in EPO

Orenitram has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 08, 2012, by Sandoz Ag. This opposition was filed on patent number EP07755989A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP04776104A Oct, 2017 Teva Pharmaceutical Industries Ltd Patent maintained as amended
EP07755989A Aug, 2012 Sandoz AG Revoked


US patents provide insights into the exclusivity only within the United States, but Orenitram is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Orenitram's family patents as well as insights into ongoing legal events on those patents.

Orenitram's family patents

Orenitram has patent protection in a total of 8 countries. It's US patent count contributes only to 50.0% of its total global patent coverage. Click below to unlock the full patent family tree for Orenitram.

Family Patents

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Generic Launch

Generic Release Date:

Orenitram's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 11, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Orenitram Generics:

There are no approved generic versions for Orenitram as of now.

How can I launch a generic of Orenitram before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Orenitram's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Orenitram's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Orenitram -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2.5 mg 24 Dec, 2015 1 22 Jan, 2031
0.25 mg and 1 mg 19 May, 2016 1 22 Jan, 2031
0.125 mg and 5 mg 28 Dec, 2020 1 11 Aug, 2031




About Orenitram

Orenitram is a drug owned by United Therapeutics Corp. It is used for treating pulmonary arterial hypertension (WHO Group 1) with oral osmotic pharmaceutical dosage forms of treprostinil. Orenitram uses Treprostinil Diolamine as an active ingredient. Orenitram was launched by United Therap in 2013.

Market Authorisation Date:

Orenitram was approved by FDA for market use on 20 December, 2013.

Active Ingredient:

Orenitram uses Treprostinil Diolamine as the active ingredient. Check out other Drugs and Companies using Treprostinil Diolamine ingredient

Treatment:

Orenitram is used for treating pulmonary arterial hypertension (WHO Group 1) with oral osmotic pharmaceutical dosage forms of treprostinil.

Dosage:

Orenitram is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.125MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 1MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 0.25MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 2.5MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 5MG BASE TABLET, EXTENDED RELEASE Prescription ORAL