WELIREG Drug Patent Profile
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Which patents cover Welireg, and what generic alternatives are available?
Welireg is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.
This drug has fifty-two patent family members in twenty-eight countries.
The generic ingredient in WELIREG is belzutifan. One supplier is listed for this compound. Additional details are available on the belzutifan profile page.
DrugPatentWatch® Generic Entry Outlook for Welireg
Welireg will be eligible for patent challenges on August 13, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 5, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for WELIREG
International Patents: | 52 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 29 |
Clinical Trials: | 3 |
Patent Applications: | 33 |
Drug Prices: | Drug price information for WELIREG |
What excipients (inactive ingredients) are in WELIREG? | WELIREG excipients list |
DailyMed Link: | WELIREG at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WELIREG
Generic Entry Date for WELIREG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for WELIREG
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme Corp. | Phase 1 |
Peloton Therapeutics, Inc. | Phase 2 |
Pharmacology for WELIREG
Drug Class | Hypoxia-inducible Factor Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inducers Hypoxia-inducible Factor 2 alpha Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for WELIREG
US Patents and Regulatory Information for WELIREG
WELIREG is protected by four US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of WELIREG is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting WELIREG
Aryl ethers and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA, CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS, NOT REQUIRING IMMEDIATE SURGERY
Aryl ethers and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA FOLLOWING A PROGRAMMED DEATH RECEPTOR-1 OR PROGRAMMED DEATH-LIGAND INHIBITOR AND A VASCULAR ENDOTHELIAL GROWTH FACTOR TYROSINE KINASE INHIBITOR
Aryl ethers and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA, CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS, NOT REQUIRING IMMEDIATE SURGERY
Aryl ethers and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA FOLLOWING A PROGRAMMED DEATH RECEPTOR-1 OR PROGRAMMED DEATH-LIGAND INHIBITOR AND A VASCULAR ENDOTHELIAL GROWTH FACTOR TYROSINE KINASE INHIBITOR
FDA Regulatory Exclusivity protecting WELIREG
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA FOLLOWING A PROGRAMMEDDEATH RECEPTOR-1 OR PROGRAMMED DEATH-LIGAND 1 INHIBITOR AND A VASCULAR ENDOTHELIAL GROWTH FACTOR TYROSINE KINASE INHIBITOR
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU (VHL) DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA (RCC), CENTRAL NERVOUS SYSTEM (CNS) HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS (PNET), NOT REQUIRING IMMEDIATE SURGERY
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for WELIREG
When does loss-of-exclusivity occur for WELIREG?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7600
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14318025
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 19397
Estimated Expiration: ⤷ Sign Up
China
Patent: 5530923
Estimated Expiration: ⤷ Sign Up
Patent: 0372550
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191298
Estimated Expiration: ⤷ Sign Up
Patent: 0201701
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 385
Estimated Expiration: ⤷ Sign Up
Patent: 160030
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23433
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2124
Estimated Expiration: ⤷ Sign Up
Patent: 1690549
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Patent: 17851
Estimated Expiration: ⤷ Sign Up
Patent: 17852
Estimated Expiration: ⤷ Sign Up
Patent: 86835
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 21667
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 45462
Estimated Expiration: ⤷ Sign Up
Patent: 52080
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3888
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 86940
Estimated Expiration: ⤷ Sign Up
Patent: 46733
Estimated Expiration: ⤷ Sign Up
Patent: 18039
Estimated Expiration: ⤷ Sign Up
Patent: 16534134
Estimated Expiration: ⤷ Sign Up
Patent: 19070043
Estimated Expiration: ⤷ Sign Up
Patent: 19089855
Estimated Expiration: ⤷ Sign Up
Patent: 19089856
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Patent: 17851
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16002974
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6281
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 160434
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Patent: 17851
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Patent: 17851
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 960
Estimated Expiration: ⤷ Sign Up
Patent: 953
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201601616S
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 43784
Estimated Expiration: ⤷ Sign Up
Patent: 17851
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2153772
Estimated Expiration: ⤷ Sign Up
Patent: 160055199
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 39433
Estimated Expiration: ⤷ Sign Up
Patent: 84454
Estimated Expiration: ⤷ Sign Up
Patent: 23477
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 57071
Estimated Expiration: ⤷ Sign Up
Patent: 1605775
Estimated Expiration: ⤷ Sign Up
Patent: 1936572
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 731
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering WELIREG around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Uruguay | 35731 | ÉTERES DE ARILO Y SUS USOS | ⤷ Sign Up |
Cyprus | 1123433 | ⤷ Sign Up | |
Eurasian Patent Organization | 032124 | АРИЛЭФИРЫ И ИХ ПРИМЕНЕНИЯ (ARYL ETHERS AND USES THEREOF) | ⤷ Sign Up |
Croatia | P20201701 | ⤷ Sign Up | |
Slovenia | 3417851 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |