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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(4 years from now) | Active |
| US8497393 | 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 |
| US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® |
Dec, 2028
(4 years from now) | Active |
| US7417070 | Compounds and methods for delivery of prostacyclin analogs |
Jul, 2026
(1 year, 8 months from now) | Active |
| US9050311 | Compounds and methods for delivery of prostacyclin analogs |
May, 2024
(5 months ago) |
Expired
|
| US6765117 | Process for stereoselective synthesis of prostacyclin derivatives |
Oct, 2017
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8747897 | Osmotic drug delivery system |
Aug, 2031
(6 years from now) | Active |
| US8349892 | Solid formulations of prostacyclin analogs |
Jan, 2031
(6 years from now) | Active |
| US8410169 | Compounds and methods for delivery of prostacyclin analogs |
Feb, 2030
(5 years from now) | Active |
| US9393203 | Osmotic drug delivery system |
Apr, 2026
(1 year, 5 months from now) | Active |
| US7544713 | Compounds and methods for delivery of prostacyclin analogs |
Jul, 2024
(4 months ago) |
Expired
|
| US9278901 | Compounds and methods for delivery of prostacyclin analogs |
May, 2024
(5 months ago) |
Expired
|
| US9422223 | Compounds and methods for delivery of prostacyclin analogs |
May, 2024
(5 months ago) |
Expired
|
| US8252839 | Compounds and methods for delivery of prostacyclin analogs |
May, 2024
(5 months ago) |
Expired
|
| US5153222 | Method of treating pulmonary hypertension with benzidine prostaglandins |
Oct, 2014
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Orenitram's patents.
Latest Legal Activities on Orenitram's Patents
Given below is the list of recent legal activities going on the following patents of Orenitram.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2024 | US8252839 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2024 | US9422223 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2024 | US9393203 (Litigated) |
| Recordation of Patent eGrant | 15 Aug, 2023 | US11723887 |
| Patent eGrant Notification | 15 Aug, 2023 | US11723887 |
| Mail Patent eGrant Notification | 15 Aug, 2023 | US11723887 |
| Email Notification Critical | 15 Aug, 2023 | US11723887 |
| Electronic Review Critical | 15 Aug, 2023 | US11723887 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Aug, 2023 | US11723887 |
| Recordation of Patent Grant Mailed Critical | 15 Aug, 2023 | US11723887 |
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 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 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 |
|---|---|---|---|---|
 | ||||
| US9604901 | March, 2020 |
FWD Entered
(08 Oct, 2021) | United Therapeutics Corp. | Liquidia Technolgies, Inc. |
| US9593066 | March, 2020 |
Terminated-Denied
(13 Oct, 2020) | United Therapeutics Corp. | Liquidia Technologies, Inc. |
| US8497393 | October, 2015 |
FWD Entered
(31 Mar, 2017) | 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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.
Approval 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 1MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 0.25MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 0.125MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 5MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 2.5MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |