Opsumit Patent Expiration

Opsumit is a drug owned by Actelion Pharmaceuticals Us Inc. It is protected by 5 US drug patents filed from 2013 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 18, 2029. Details of Opsumit's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7094781 Sulfamides and their use as endothelin receptor antagonists
Dec, 2025

(1 year, 4 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10946015 Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Sep, 2026

(2 years from now)

US9265762 Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
May, 2027

(2 years from now)

US8367685 Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Oct, 2028

(4 years from now)

US8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Apr, 2029

(4 years from now)


FDA has granted several exclusivities to Opsumit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Opsumit, 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 Opsumit.

Exclusivity Information

Opsumit holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Opsumit's exclusivity codes and their expiration dates are given below.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 18, 2018
Orphan Drug Exclusivity(ODE) Oct 18, 2020
Orphan Drug Exclusivity(ODE-54) Oct 18, 2020

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US patents provide insights into the exclusivity only within the United States, but Opsumit 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 Opsumit's family patents as well as insights into ongoing legal events on those patents.

Opsumit's family patents

Opsumit has patent protection in a total of 34 countries. It's US patent count contributes only to 18.0% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Opsumit.

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Generic Launch

Generic Release Date:

Opsumit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 18, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Opsumit Generics:

Macitentan is the generic name for the brand Opsumit. 3 different companies have already filed for the generic of Opsumit, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Opsumit's generic

How can I launch a generic of Opsumit before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Opsumit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Opsumit'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 Opsumit -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg 18 Oct, 2017 11 06 Apr, 2021 18 Apr, 2029 Eligible

About Opsumit

Opsumit is a drug owned by Actelion Pharmaceuticals Us Inc. It is used for treating pulmonary arterial hypertension. Opsumit uses Macitentan as an active ingredient. Opsumit was launched by Actelion in 2013.

Market Authorisation Date:

Opsumit was approved by FDA for market use on 18 October, 2013.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Opsumit is 18 October, 2013, its NCE-1 date is estimated to be 18 October, 2017

Active Ingredient:

Opsumit uses Macitentan as the active ingredient. Check out other Drugs and Companies using Macitentan ingredient


Opsumit is used for treating pulmonary arterial hypertension.


Opsumit is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG TABLET Prescription ORAL