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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Merck Sharp Dohme | WELIREG | belzutifan | TABLET;ORAL | 215383-001 | Aug 13, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Australia
Patent: 14318025
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 19397
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5530923
Estimated Expiration: ⤷ Try a Trial
Patent: 0372550
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191298
Estimated Expiration: ⤷ Try a Trial
Patent: 0201701
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 385
Estimated Expiration: ⤷ Try a Trial
Patent: 160030
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 23433
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2124
Estimated Expiration: ⤷ Try a Trial
Patent: 1690549
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Patent: 17851
Estimated Expiration: ⤷ Try a Trial
Patent: 17852
Estimated Expiration: ⤷ Try a Trial
Patent: 86835
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 21667
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 45462
Estimated Expiration: ⤷ Try a Trial
Patent: 52080
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3888
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 86940
Estimated Expiration: ⤷ Try a Trial
Patent: 46733
Estimated Expiration: ⤷ Try a Trial
Patent: 18039
Estimated Expiration: ⤷ Try a Trial
Patent: 16534134
Estimated Expiration: ⤷ Try a Trial
Patent: 19070043
Estimated Expiration: ⤷ Try a Trial
Patent: 19089855
Estimated Expiration: ⤷ Try a Trial
Patent: 19089856
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Patent: 17851
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 16002974
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 6281
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 160434
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Patent: 17851
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Patent: 17851
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 960
Estimated Expiration: ⤷ Try a Trial
Patent: 953
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201601616S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Patent: 17851
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2153772
Estimated Expiration: ⤷ Try a Trial
Patent: 160055199
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 39433
Estimated Expiration: ⤷ Try a Trial
Patent: 84454
Estimated Expiration: ⤷ Try a Trial
Patent: 23477
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 57071
Estimated Expiration: ⤷ Try a Trial
Patent: 1605775
Estimated Expiration: ⤷ Try a Trial
Patent: 1936572
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 731
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Hungary | E052080 | ⤷ Try a Trial | |
| Taiwan | 201936572 | Aryl ethers and uses thereof | ⤷ Try a Trial |
| Japan | 2019089856 | アリールエーテルおよびその使用 (ARYL ETHER AND USE THEREOF) | ⤷ Try a Trial |
| Lithuania | 3043784 | ⤷ Try a Trial | |
| Japan | 2019089855 | アリールエーテルおよびその使用 (ARYL ETHER AND USE THEREOF) | ⤷ Try a Trial |
| Croatia | P20191298 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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