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) | Active |
| 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) | Active |
| US9265762 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide |
May, 2027
(2 years from now) | Active |
| US8367685 | Stable pharmaceutical compositions comprising a pyrimidine-sulfamide |
Oct, 2028
(4 years from now) | Active |
| US8268847 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor |
Apr, 2029
(4 years 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 Opsumit's patents.
Latest Legal Activities on Opsumit's Patents
Given below is the list of recent legal activities going on the following patents of Opsumit.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Mar, 2024 | US8268847 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Aug, 2023 | US9265762 |
| Patent Issue Date Used in PTA Calculation | 16 Mar, 2021 | US10946015 |
| Recordation of Patent Grant Mailed | 16 Mar, 2021 | US10946015 |
| Email Notification | 26 Feb, 2021 | US10946015 |
| Issue Notification Mailed | 24 Feb, 2021 | US10946015 |
| Dispatch to FDC | 12 Feb, 2021 | US10946015 |
| Email Notification | 11 Feb, 2021 | US10946015 |
| Mailing Corrected Notice of Allowability | 11 Feb, 2021 | US10946015 |
| Corrected Notice of Allowability | 26 Jan, 2021 | US10946015 |
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 |
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
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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
Treatment:
Opsumit is used for treating pulmonary arterial hypertension.
Dosage:
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 |