Camzyos (Mavacamten): The 2034-2036 Generic Opportunity Window

Bristol Myers Squibb's first-in-class small-molecule cardiac myosin inhibitor approved under FDA NDA 214998 (2.5 mg, 5 mg, 10 mg, and 15 mg oral capsules) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM). Synthesized with a chiral pyrimidinedione core containing an N3-isopropyl group and an (S)-(1-phenylethyl)amino substituent at C6, mavacamten selectively and reversibly binds to beta-cardiac myosin heavy chain, stabilizing the auto-inhibited 'super-relaxed' (SRX) state. This diminishes excessive actin-myosin cross-bridge formation, reduces dynamic left ventricular outflow tract (LVOT) gradients, and alleviates myocardial hypercontractility without relying on blunt negative inotropes. Camzyos generated over $1.0 billion in 2025 net global sales (+77% year-over-year), on trajectory toward peak annual revenues of $3.5B to $4.0+ billion USD across obstructive and non-obstructive HCM. Primary substance patent US 9,181,200 expires on June 19, 2034 (~7.7 years in the future relative to October 24, 2026), secondary method patent US 9,585,883 expires June 19, 2034, and reissue patent US RE50,050 extends Orange Book protection through April 28, 2036 (~9.5 years in the future). Commercial generic status: 100% brand-only in the United States today; zero generic mavacamten is approved or commercially distributed in the U.S. Hatch-Waxman 5-year NCE exclusivity runs to April 28, 2027; Paragraph IV ANDA filings opened on April 28, 2026 (NCE-1). Major global and Indian generic developers (MSN Laboratories, Dr. Reddy's Laboratories, Natco Pharma, Hetero Labs, Sun Pharma, Cipla, and Alembic Pharmaceuticals) are actively preparing API synthesis routes, chiral separation technologies, and DMF filings targeting the 2034-2036 generic challenge window.