Rozlytrek generics — when can they launch?
Rozlytrek (entrectinib) · Roche · 28 active US patents · 0 expired
Where Rozlytrek sits in the generic timeline
Imminent generic cliff: earliest active US patent for Rozlytrek expires in 2028 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 16 patents
- Composition of Matter — 6 patents
- Formulation — 6 patents
FDA U-codes carved out by Rozlytrek 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-2618 | (no description) |
U-2745 | (no description) |
U-2617 | (no description) |
U-2946 | (no description) |
Sample patent estate
Showing 6 of 28 active US patents. View full estate on the Rozlytrek drug page →
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This patent discloses substituted indazole derivatives and their use in pharmaceutical compositions for treating diseases associated with deregulated protein kinase activity.USPTO title: Substituted indazole derivatives active as kinase inhibitors
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This patent protects substituted indazole derivatives that can be used as kinase inhibitors in the treatment of diseases associated with deregulated protein kinase activity.USPTO title: Substituted indazole derivatives active as kinase inhibitors
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USPTO title: Substituted indazole derivatives active as kinase inhibitors
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This patent protects substituted indazole derivatives and their pharmaceutically acceptable salts, which are kinase inhibitors.USPTO title: Substituted indazole derivatives active as kinase inhibitors
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This patent protects substituted indazole derivatives that can be used as kinase inhibitors in the treatment of diseases associated with deregulated protein kinase activity.USPTO title: Substituted indazole derivatives active as kinase inhibitors
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This patent protects substituted indazole derivatives and their pharmaceutically acceptable salts, which are kinase inhibitors.USPTO title: Substituted indazole derivatives active as kinase inhibitors
Sources
- FDA Orange Book — patents listed against Rozlytrek (NDA filed 2019)
- Rozlytrek drug profile — full patent estate, indications, clinical trials, pricing
- Roche patent portfolio
- Patent cliff 2028 — 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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