Welireg is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 5 US drug patents filed from 2021 to 2026 out of which none have expired yet. Welireg's patents have been open to challenges since 13 August, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 30, 2042. 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. | |||
| US9969689 | Aryl ethers and uses thereof |
Sep, 2034
(7 years from now) | Active |
| USRE49948 | Aryl ethers and uses thereof |
Sep, 2034
(7 years from now) | Active |
| US9908845 | Aryl ethers and uses thereof |
Sep, 2034
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12358870 | Solid Dispersions And Pharmaceutical Compositions Comprising A Substituted Indane And Methods For The Preparation And Use Thereof |
Jun, 2042
(15 years from now) | Active |
| US10335388 | Combination Therapy Of A Hif-2-Alpha Inhibitor And An Immunotherapeutic Agent And Uses Thereof |
Apr, 2036
(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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Oct, 2025 | USRE49948 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Aug, 2025 | US9908845 |
| Recordation of Patent Grant Mailed | 22 Jul, 2025 | US12358870 |
| Email Notification | 16 Jul, 2025 | US12358870 |
| Recordation of Patent eGrant | 15 Jul, 2025 | US12358870 |
| Mail Patent eGrant Notification | 15 Jul, 2025 | US12358870 |
| Patent Issue Date Used in PTA Calculation | 15 Jul, 2025 | US12358870 |
| Patent eGrant Notification | 15 Jul, 2025 | US12358870 |
| Email Notification | 03 Jul, 2025 | US12358870 |
| Issue Notification Mailed | 02 Jul, 2025 | US12358870 |
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 5 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. 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 |
| New Indication(I-968) | May 14, 2028 |
| Orphan Drug Exclusivity(ODE-364) | Aug 13, 2028 |
| New Indication(I-994) | Jun 12, 2029 |
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
Clinical Trials
Recent Clinical Trials on Welireg:
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.
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 Jun 30, 2042 (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.
How can I launch a generic of Welireg before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Welireg's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Welireg'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 Welireg -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Aug, 2025 | 30 Jun, 2042 | Moderate |
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 in 2021.
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 |