MAVACAMTEN - Generic Drug Details

What are the generic 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-four patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for MAVACAMTEN

International Patents:	64
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	14
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

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 3
Bristol-Myers Squibb	Phase 1
LianBio LLC	Phase 3

See all MAVACAMTEN clinical trials

Pharmacology for MAVACAMTEN

Drug Class	Cardiac Myosin Inhibitor
Mechanism of Action	Cardiac Myosin Inhibitors

US Patents and Regulatory Information for MAVACAMTEN

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	214998-003	Apr 28, 2022		RX	Yes	No			Y	Y
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-001	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-004	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-003	Apr 28, 2022		RX	Yes	No
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998-002	Apr 28, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for MAVACAMTEN

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

International Patents for MAVACAMTEN

Country	Patent Number	Title	Estimated Expiration
New Zealand	715456	Pyrimidinedione compounds against cardiac conditions
China	105473576	Pyrimidinedione compounds against cardiac conditions
Canada	2915967	COMPOSES DE PYRIMIDINE-DIONE CONTRE LES AFFECTIONS CARDIAQUES (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS)
China	109384729	针对心脏病症的嘧啶二酮化合物 (Pyrimidinedione compounds against cardiac conditions)
Denmark	3010910
Croatia	P20200379
Malaysia	190860	PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS

Supplementary Protection Certificates for MAVACAMTEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3010910	LUC00324	Luxembourg		PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
3010910	CR 2023 00034	Denmark		PRODUCT NAME: MAVACAMTEN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1716 20230627
3010910	PA2023535	Lithuania		PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	122023000063	Germany		PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910	39/2023	Austria		PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 (MITTTEILUNG) 20230627
3010910	2023C/546	Belgium		PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
3010910	301253	Netherlands		PRODUCT NAME: MAVACAMTEN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1716 20230627