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 (Pediatric) | Therapeutic Compositions Comprising A Specific Endothelin Receptor Antagonist And A Pde5 Inhibitor | Oct 18, 2029 | Actelion |
| Opsumit | US8268847 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor | Apr 18, 2029 | Actelion |
| Opsumit |
US8367685 (Pediatric) | Stable Pharmaceutical Compositions Comprising A Pyrimidine-Sulfamide | Apr 04, 2029 | Actelion |
| Opsumit | US8367685 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide | Oct 04, 2028 | Actelion |
| Opsumit |
US9265762 (Pediatric) | Stable Pharmaceutical Compositions Comprising A Pyrimidine-Sulfamide | Nov 29, 2027 | Actelion |
| Opsumit | US9265762 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide | May 29, 2027 | Actelion |
| Opsumit |
US10946015 (Pediatric) | Stable Pharmaceutical Compositions Comprising A Pyrimidine-Sulfamide | Mar 11, 2027 | Actelion |
| Opsumit | US10946015 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide |
Sep 11, 2026
(Expired) | Actelion |
| Opsumit |
US7094781 (Pediatric) | Sulfamides And Their Use As Endothelin Receptor Antagonists |
Jun 05, 2026
(Expired) | Actelion |
| Opsumit | US7094781 | Sulfamides and their use as endothelin receptor antagonists |
Dec 05, 2025
(Expired) | Actelion |
Macitentan's Family Patents
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Clinical Trials
Recent Clinical Trials on Macitentan:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH | Dr Sudarshan Rajagopal | NA |
TERMINATED
(Aug 1, 2026)
| PHASE3 |
| A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option | Actelion | NA |
RECRUITING
(Aug 1, 2026)
| PHASE3 |
| A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension | Janssen Pharmaceutical K.K. | NA |
COMPLETED
(Apr 1, 2026)
| PHASE3 |
| A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) | Actelion | NA |
COMPLETED
(Mar 1, 2026)
| PHASE3 |