Treprostinil Patent Expiration
Treprostinil is Used for treating pulmonary hypertension, specifically associated with interstitial lung disease, by administering treprostinil or a salt thereof through inhalation. It was first introduced by United Therapeutics Corp
Treprostinil Patents
Given below is the list of patents protecting Treprostinil, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Remodulin | US10076505 | Inhalation formulations of Treprostinil | Dec 16, 2024 | United Therap |
| Remodulin | US10695308 | Inhalation formulations of treprostinil | Dec 16, 2024 | United Therap |
| Remodulin | US11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Remodulin | US5153222 | Method of treating pulmonary hypertension with benzidine prostaglandins |
Oct 06, 2014
(Expired) | United Therap |
| Remodulin | US6765117 | Process for stereoselective synthesis of prostacyclin derivatives |
Oct 24, 2017
(Expired) | United Therap |
| Remodulin | US7999007 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same | Mar 29, 2029 | United Therap |
| Remodulin | US8497393 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Remodulin | US8653137 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same | Sep 05, 2028 | United Therap |
| Remodulin | US8658694 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same | Sep 05, 2028 | United Therap |
| Remodulin | US9199908 | Compounds and methods for delivery of prostacyclin analogs |
May 24, 2024
(Expired) | United Therap |
| Remodulin | US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® | Dec 15, 2028 | United Therap |
| Remodulin | US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Remodulin | US9713599 | Parenteral formulations of treprostinil | Dec 16, 2024 | United Therap |
| Tyvaso | US10376525 | Treprostinil administration by inhalation | May 14, 2027 | United Therap |
| Tyvaso | US10716793 | Treprostinil administration by inhalation | May 14, 2027 | United Therap |
| Tyvaso | US11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso | US11826327 | Treatment for interstitial lung disease | Feb 03, 2042 | United Therap |
| Tyvaso | US5153222 | Method of treating pulmonary hypertension with benzidine prostaglandins |
Oct 16, 2014
(Expired) | United Therap |
| Tyvaso | US6521212 | Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation |
Nov 13, 2018
(Expired) | United Therap |
| Tyvaso | US6756033 | Method for delivering benzindene prostaglandins by inhalation |
Nov 13, 2018
(Expired) | United Therap |
| Tyvaso | US6765117 | Process for stereoselective synthesis of prostacyclin derivatives |
Oct 24, 2017
(Expired) | United Therap |
| Tyvaso | US8497393 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso | US9339507 | Treprostinil administration by inhalation | Mar 10, 2028 | United Therap |
| Tyvaso | US9358240 | Treprostinil administration by inhalation | May 05, 2028 | United Therap |
| Tyvaso | US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso | US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso Dpi | US10130685 | Diketopiperazine salts for drug delivery and related methods | Aug 23, 2025 | United Therap |
| Tyvaso Dpi | US10421729 | Microcrystalline diketopiperazine compositions and methods | Apr 01, 2035 | United Therap |
| Tyvaso Dpi | US10716793 | Treprostinil administration by inhalation | May 14, 2027 | United Therap |
| Tyvaso Dpi | US10772883 | Diketopiperazine microparticles with defined specific surface areas | Jun 11, 2030 | United Therap |
| Tyvaso Dpi | US11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso Dpi | US11826327 | Treatment for interstitial lung disease | Feb 03, 2042 | United Therap |
| Tyvaso Dpi | US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® | Dec 15, 2028 | United Therap |
| Tyvaso Dpi | US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® | Dec 15, 2028 | United Therap |
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 Treprostinil's patents.
Latest Legal Activities on Treprostinil's Patents
Given below is the list recent legal activities going on the following patents of Treprostinil.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Mar, 2024 | US10772883 |
| Email Notification | 09 Mar, 2024 | US11826327 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 08 Mar, 2024 | US11826327 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 08 Mar, 2024 | US11826327 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 07 Mar, 2024 | US11826327 |
| Adjustment of PTA Calculation by PTO | 07 Mar, 2024 | US11826327 |
| Pet Dec Routed to Certificate of Corrections Branch | 07 Mar, 2024 | US11826327 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2024 | US10716793 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2023 | US10695308 |
| Petition Entered | 30 Nov, 2023 | US11826327 |
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Treprostinil Generics
Several generic applications have been filed for Treprostinil. The first generic version for Treprostinil was by Sandoz Inc and was approved on Nov 30, 2017. And the latest generic version is by Alembic Global Holding Sa and was approved on Feb 11, 2021.
Given below is the list of companies who have filed for Treprostinil generic.
1. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Treprostinil. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | May 22, 2020 |
| 2.5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | May 22, 2020 |
| 5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | May 22, 2020 |
| 10MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | May 22, 2020 |
2. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Treprostinil. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 26, 2019 |
| 2.5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 26, 2019 |
| 5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 26, 2019 |
| 10MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 26, 2019 |
3. SANDOZ
Sandoz Inc has filed for 4 different strengths of generic version for Treprostinil. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Nov 30, 2017 |
| 5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Nov 30, 2017 |
| 2.5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Nov 30, 2017 |
| 1MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Nov 30, 2017 |
4. ALEMBIC GLOBAL
Alembic Global Holding Sa has filed for 4 different strengths of generic version for Treprostinil. Given below are the details of the strengths of this generic introduced by Alembic Global.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Feb 11, 2021 |
| 10MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Feb 11, 2021 |
| 5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Feb 11, 2021 |
| 2.5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Feb 11, 2021 |
5. ENDO OPERATIONS
Endo Operations Ltd has filed for 4 different strengths of generic version for Treprostinil. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 24, 2019 |
| 10MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 24, 2019 |
| 5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 24, 2019 |
| 2.5MG/ML | injectable | Prescription | IV (INFUSION), SUBCUTANEOUS | AP | Sep 24, 2019 |