Viewing data from:

CAMZYOS

NDA

MAVACAMTEN | N214998 | BRISTOL MYERS SQUIBB CO

4 strengths2 unique patents3 unique exclusivities

Patent Timeline

2 unique patents, 3 exclusivities by expiration date

Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

RE50050

Apr. 28, 2036

9585883

Jun. 19, 2034

M-297

Jun. 15, 2026

NCE

Apr. 28, 2027

ODE-398

Apr. 28, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)NCT07541833	—	Recruiting	Bristol-Myers Squibb	36	2026-02-05 → 2026-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Camzyos (2023)

Total Spending

$105.1M

Total Claims

12,703

Beneficiaries

2,006

Avg Cost/Unit

$276.69

Spending Trend

$8.1M(2022)→$105.1M(2023)

YoY Change:+7.9%

5yr CAGR:+7.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs

11 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLMAVACAMTEN

DMF 384622023

MAITHRI DRUGS PRIVATE LTDMAVACAMTEN

DMF 397722024

DR REDDYS LABORATORIES LTDMAVACAMTEN

DMF 410812024

DASAMI LAB PRIVATE LTDMAVACAMTEN

DMF 413262025

VIYASH LIFE SCIENCES PRIVATE LTDMAVACAMTEN

DMF 413622025

MICRO LABS LTDMavacamten

DMF 414182025

APICHEM LABORATORIES PRIVATE LTDMAVACAMTEN

DMF 414992025

XUZHOU WANBANG JINQIAO PHARMA CO LTDMAVACAMTEN

DMF 422482025

METROCHEM API PRIVATE LTDMAVACAMTEN

DMF 424942025

APITORIA PHARMA PRIVATE LTDMAVACAMTEN

DMF 426532025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMAVACAMTEN

DMF 428802025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2025	SUPPL -10	View Letter (PDF)
May 2, 2024	SUPPL -9	View Letter (PDF)
May 2, 2024	SUPPL -9	View Letter (PDF)
Dec 20, 2023	SUPPL -8	View Letter (PDF)
Jun 16, 2023	SUPPL -1	View Letter (PDF)
Jan 17, 2023	SUPPL -4	View Letter (PDF)
Nov 25, 2022	SUPPL -3	View Letter (PDF)
Apr 29, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.5MG

RLD

2 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Apr 28, 2022

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE50050	Apr 28, 2036	—	Yes	Yes	—	—
9585883	Jun 19, 2034	—	—	—		—

Exclusivities (3)

Code	Date	Status
M-297	Jun 15, 2026	Expired
NCE	Apr 28, 2027	< 1 year
ODE-398	Apr 28, 2029	Active

#002 — 5MG

RLD

2 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Apr 28, 2022

#003 — 10MG

RLD

2 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Apr 28, 2022

#004 — 15MG

RLD

2 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Apr 28, 2022