Macitentan Patent Expiration
Macitentan is used for treating pulmonary arterial hypertension. It was first introduced by Actelion Pharmaceuticals Us Inc
Macitentan Patents
Given below is the list of patents protecting Macitentan, 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 |
|---|---|---|---|---|
| Opsumit | US8268847 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor | Apr 18, 2029 | Actelion |
| Opsumit | US8367685 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide | Oct 04, 2028 | Actelion |
| Opsumit | US9265762 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide | May 29, 2027 | Actelion |
| Opsumit | US10946015 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide | Sep 11, 2026 | Actelion |
| Opsumit | US7094781 | Sulfamides and their use as endothelin receptor antagonists | Dec 05, 2025 | Actelion |
Macitentan's Family Patents
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Macitentan Generics
Several generic applications have been filed for Macitentan. The first generic version for Macitentan was by Zydus Lifesciences Global Fze and was approved on Apr 6, 2021. And the latest generic version is by Torrent Pharmaceuticals Ltd and was approved on Aug 5, 2024.
Given below is the list of companies who have filed for Macitentan generic.
1. APOTEX
Apotex Inc has filed for 1 generic for Macitentan. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Jan 9, 2024 |
2. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Macitentan. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Apr 18, 2023 |
3. TORRENT
Torrent Pharmaceuticals Ltd has filed for 1 generic for Macitentan. Given below are the details of the strengths of this generic introduced by Torrent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Aug 5, 2024 |
4. ZYDUS LIFESCIENCES
Zydus Lifesciences Global Fze has filed for 1 generic for Macitentan. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Discontinued | ORAL | N/A | Apr 6, 2021 |