Mavacamten - Generic Drug Details

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

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

Mavacamten has sixty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for mavacamten

International Patents:	67
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	15
Patent Applications:	24
What excipients (inactive ingredients) are in mavacamten?	mavacamten excipients list
DailyMed Link:	mavacamten at DailyMed

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

Generic Entry Date for mavacamten^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS Dosage: CAPSULE;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 mavacamten

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 4
Bristol-Myers Squibb	Phase 3
Bristol-Myers Squibb	Phase 1

See all mavacamten clinical trials

Pharmacology for mavacamten

Drug Class	Cardiac Myosin Inhibitor
Mechanism of Action	Cardiac Myosin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mavacamten

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for mavacamten

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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
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No	⤷ 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

EU/EMA Drug Approvals for mavacamten

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Camzyos	mavacamten	EMEA/H/C/005457 Treatment of symptomatic obstructive hypertrophic cardiomyopathy.	Authorised	no	no	no	2023-06-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for mavacamten

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Country	Patent Number	Title	Estimated Expiration
Guatemala	201500348	COMPUESTOS DE PIRIMIDINODIONA CONTRA ESTADOS CARDÍACOS	⤷ Sign Up
Israel	285971	תרכובות פירימידינדיאון נגד הפרעות לבביות (Pyrimidinedione compounds against cardiac conditions)	⤷ Sign Up
Mexico	2015017865	COMPUESTOS DE PIRIMIDINODIONA CONTRA ESTADOS CARDIACOS. (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for mavacamten

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3010910	39/2023	Austria	⤷ Sign Up	PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 (MITTTEILUNG) 20230627
3010910	PA2023535	Lithuania	⤷ Sign Up	PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	LUC00324	Luxembourg	⤷ Sign Up	PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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