BELZUTIFAN - Generic Drug Details

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What are the generic drug sources for belzutifan and what is the scope of patent protection?

Belzutifan is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Belzutifan has fifty-three patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for BELZUTIFAN

International Patents:	53
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	20
Patent Applications:	49
What excipients (inactive ingredients) are in BELZUTIFAN?	BELZUTIFAN excipients list
DailyMed Link:	BELZUTIFAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BELZUTIFAN

Generic Entry Date for BELZUTIFAN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 BELZUTIFAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins Bloomberg School of Public Health	Phase 2
Merck Sharp & Dohme LLC	Phase 1/Phase 2
Merck Sharp & Dohme LLC	Phase 3

See all BELZUTIFAN clinical trials

Pharmacology for BELZUTIFAN

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 BELZUTIFAN

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BELZUTIFAN

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Glossary

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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				⤷ 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 BELZUTIFAN

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3417852	ÉTHERS D'ARYLE ET LEURS UTILISATIONS (ARYL ETHERS AND USES THEREOF)	⤷ Sign Up
Japan	6746733		⤷ Sign Up
Spain	2784454		⤷ Sign Up
Australia	2014318025	Aryl ethers and uses thereof	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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