Camzyos generics — when can they launch?
Camzyos (MAVACAMTEN) · Bristol-Myers Squibb · 8 active US patents · 0 expired
Where Camzyos sits in the generic timeline
Long-dated protection: earliest active US patent for Camzyos extends to 2034 (~8 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 4 patents
- Composition of Matter — 4 patents
FDA U-codes carved out by Camzyos patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-3373 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Camzyos drug page →
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This patent protects novel pyrimidine dione compounds and their salts for treating hypertrophic cardiomyopathy and related heart conditions.USPTO title: Pyrimidinedione compounds
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This patent protects novel pyrimidine dione compounds and their salts for treating hypertrophic cardiomyopathy and related heart conditions.USPTO title: Pyrimidinedione compounds
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This patent protects novel pyrimidine dione compounds and their salts for treating hypertrophic cardiomyopathy and related heart conditions.USPTO title: Pyrimidinedione compounds
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This patent protects novel pyrimidine dione compounds and their salts for treating hypertrophic cardiomyopathy and related heart conditions.USPTO title: Pyrimidinedione compounds
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This patent protects the active drug substance Camzyos.
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This patent protects the active drug substance Camzyos.
Sources
- FDA Orange Book — patents listed against Camzyos (NDA filed 2022)
- Camzyos drug profile — full patent estate, indications, clinical trials, pricing
- Bristol-Myers Squibb patent portfolio
- Patent cliff 2034 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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