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CAMZYOS Drug Patent Profile

When do Camzyos patents expire, and when can generic versions of Camzyos launch?

Camzyos is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-four patent family members in thirty-nine countries.

The generic ingredient in CAMZYOS is mavacamten. One supplier is listed for this compound. Additional details are available on the mavacamten profile page.

DrugPatentWatch^® Generic Entry Outlook for Camzyos

Camzyos will be eligible for patent challenges on April 28, 2026. 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 June 19, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAMZYOS

International Patents:	64
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	16
Drug Prices:	Drug price information for CAMZYOS
What excipients (inactive ingredients) are in CAMZYOS?	CAMZYOS excipients list
DailyMed Link:	CAMZYOS at DailyMed

See drug prices for CAMZYOS

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

NDA:

214998

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.

Anatomical Therapeutic Chemical (ATC) Classes for CAMZYOS

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

US Patents and Regulatory Information for CAMZYOS

CAMZYOS is protected by two US patents and three FDA Regulatory Exclusivities.

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 CAMZYOS

FDA Regulatory Exclusivity protecting CAMZYOS

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

EU/EMA Drug Approvals for CAMZYOS

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 CAMZYOS

When does loss-of-exclusivity occur for CAMZYOS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Finland

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 CAMZYOS around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2015003689	Compuestos derivados de 6-(bencil, heteroaril)aminopirimidina-2,4(1h,3h)-diona y sus sales; composicion farmaceutica que los comprende; y su uso para tratar una cardiomiopatia hipertrofica (hcm) o un trastorno cardiaco que tiene una caracteristica patofisiologica asociada con hcm.
Malaysia	190860	PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS
Israel	302299	תרכובות פירימידינדיאון נגד הפרעות לבביות (Pyrimidinedione compounds against cardiac conditions)
New Zealand	715456	Pyrimidinedione compounds against cardiac conditions

Supplementary Protection Certificates for CAMZYOS

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	2023C/546	Belgium		PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627