Opsynvi is a drug owned by Actelion Pharmaceuticals Us Inc. It is protected by 6 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 22, 2031. Details of Opsynvi'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. | |||
| US7094781 | Sulfamides and their use as endothelin receptor antagonists |
Dec, 2025
(30 days from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8268847 (Pediatric) | NA |
Oct, 2029
(3 years from now) | Active |
| US8268847 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor |
Apr, 2029
(3 years from now) | Active |
|
US10946015 (Pediatric) | NA |
Mar, 2027
(1 year, 4 months from now) | Active |
| US10946015 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide |
Sep, 2026
(10 months from now) | Active |
|
US7094781 (Pediatric) | NA |
Jun, 2026
(6 months from now) | Active |
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 Opsynvi's patents.
Latest Legal Activities on Opsynvi's Patents
Given below is the list of recent legal activities going on the following patents of Opsynvi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Mar, 2024 | US8268847 |
| Patent Issue Date Used in PTA Calculation
Critical | 16 Mar, 2021 | US10946015 |
| Recordation of Patent Grant Mailed
Critical | 16 Mar, 2021 | US10946015 |
| Email Notification
Critical | 26 Feb, 2021 | US10946015 |
| Issue Notification Mailed
Critical | 24 Feb, 2021 | US10946015 |
| Dispatch to FDC | 12 Feb, 2021 | US10946015 |
| Mailing Corrected Notice of Allowability | 11 Feb, 2021 | US10946015 |
| Email Notification
Critical | 11 Feb, 2021 | US10946015 |
| Corrected Notice of Allowability | 26 Jan, 2021 | US10946015 |
| Information Disclosure Statement considered
Critical | 26 Jan, 2021 | US10946015 |
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 Opsynvi and ongoing
litigations to
help you estimate the early arrival of Opsynvi generic.
Opsynvi's Litigations
Opsynvi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 10, 2025, against patent number US8268847. The petitioner United Therapeutics Corporation, challenged the validity of this patent, with Actelion Pharmaceuticals Ltd. et al. as the respondent. Click below to track the latest information on how companies are challenging Opsynvi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8268847 | June, 2025 | Pending | Actelion Pharmaceuticals Ltd. et al. | United Therapeutics Corporation |
FDA has granted some exclusivities to Opsynvi. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Opsynvi,
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
Opsynvi.
Exclusivity Information
Opsynvi holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Opsynvi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 22, 2027 |
| Orphan Drug Exclusivity(ODE-475) | Mar 22, 2031 |
| Pediatric Exclusivity(PED) | Sep 22, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Opsynvi 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 Opsynvi's family patents as well as insights into
ongoing legal events
on those patents.
Opsynvi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Opsynvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 22, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Opsynvi Generics:
There are no approved generic versions for Opsynvi as of now.
About Opsynvi
Opsynvi is a drug owned by Actelion Pharmaceuticals Us Inc. Opsynvi uses Macitentan; Tadalafil as an active ingredient. Opsynvi was launched by Actelion in 2024.
Approval Date:
Opsynvi was approved by FDA for market use on 22 March, 2024.
Active Ingredient:
Opsynvi uses Macitentan; Tadalafil as the active ingredient. Check out other Drugs and Companies using Macitentan; Tadalafil ingredient
Dosage:
Opsynvi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;40MG | TABLET | Prescription | ORAL |
| 10MG;20MG | TABLET | Prescription | ORAL |