Welireg is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 3 US drug patents filed from 2021 to 2024 out of which none have expired yet. Welireg's patents will be open to challenges from 13 August, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2034. Details of Welireg'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. | |||
| USRE49948 | Aryl ethers and uses thereof |
Sep, 2034
(9 years from now) | Active |
| US9969689 | Aryl ethers and uses thereof |
Sep, 2034
(9 years from now) | Active |
| US9908845 | Aryl ethers and uses thereof |
Sep, 2034
(9 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 Welireg's patents.
Latest Legal Activities on Welireg's Patents
Given below is the list of recent legal activities going on the following patents of Welireg.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9969689 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9908845 |
| transaction for FDA Determination of Regulatory Review Period | 11 Dec, 2023 | US9969689 |
| transaction for FDA Determination of Regulatory Review Period | 11 Dec, 2023 | US9908845 |
| Second letter to regulating agency to determine regulatory review period | 30 May, 2023 | US9969689 |
| Second letter to regulating agency to determine regulatory review period | 30 May, 2023 | US9908845 |
| Letter from FDA or Dept of Agriculture re PTE application | 13 Sep, 2022 | US9969689 |
| Letter from FDA or Dept of Agriculture re PTE application | 13 Sep, 2022 | US9908845 |
| Patent Term Extension (156) Dismissed Critical | 12 Jan, 2022 | US9969689 |
| Patent Term Extension (156) Dismissed Critical | 12 Jan, 2022 | US9908845 |
FDA has granted several exclusivities to Welireg. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Welireg, 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 Welireg.
Exclusivity Information
Welireg holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Welireg's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 13, 2026 |
| New Indication(I-931) | Dec 14, 2026 |
| Orphan Drug Exclusivity(ODE-364) | Aug 13, 2028 |
US patents provide insights into the exclusivity only within the United States, but Welireg 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 Welireg's family patents as well as insights into ongoing legal events on those patents.
Welireg's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Welireg's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 05, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Welireg Generics:
There are no approved generic versions for Welireg as of now.
About Welireg
Welireg is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is used for treating advanced renal cell carcinoma after previous treatment with specific inhibitors. Welireg uses Belzutifan as an active ingredient. Welireg was launched by Merck Sharp Dohme in 2021.
Can you believe Welireg received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Welireg was approved by FDA for market use on 13 August, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Welireg is 13 August, 2021, its NCE-1 date is estimated to be 13 August, 2025.
Active Ingredient:
Welireg uses Belzutifan as the active ingredient. Check out other Drugs and Companies using Belzutifan ingredient
Treatment:
Welireg is used for treating advanced renal cell carcinoma after previous treatment with specific inhibitors.
Dosage:
Welireg is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |