Belzutifan - Generic Drug Details

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What are the generic drug sources for belzutifan and what is the scope of freedom to operate?

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				⤷ 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	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 belzutifan

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Country	Patent Number	Title	Estimated Expiration
Cuba	24385	COMPUESTOS ÉTERES DE ARILO ÚTILES PARA TRATAR CANCER DE CÉLULA RENAL	⤷ Sign Up
Lithuania	3417851		⤷ Sign Up
Japan	2019089855	アリールエーテルおよびその使用 (ARYL ETHER AND USE THEREOF)	⤷ Sign Up
Mexico	2016002974	ETERES DE ARILO Y SUS USOS. (ARYL ETHERS AND USES THEREOF.)	⤷ Sign Up
Hong Kong	1221667	芳基醚及其用途 (ARYL ETHERS AND USES THEREOF)	⤷ Sign Up
Spain	2823477		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.