Hernexeos generics — when can they launch?
Hernexeos (ZONGERTINIB) · Boehringer Ingelheim · 2 active US patents · 0 expired
Where Hernexeos sits in the generic timeline
All listed Orange Book patents for Hernexeos have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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.
- Composition of Matter — 1 patent
- Method of Use — 1 patent
FDA U-codes carved out by Hernexeos 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-4245 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Hernexeos drug page →
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This patent protects a class of compounds useful as type I receptor tyrosine kinase inhibitors for treating hyperproliferative diseases in mammals.USPTO title: N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
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This patent protects new compounds and their use as inhibitors of the HER2 protein and its mutants in treating and preventing oncological diseases.USPTO title: Substituted pyrimido[5,4-d]pyrimidines as HER2 inhibitors
Sources
- FDA Orange Book — patents listed against Hernexeos (NDA filed 2025)
- Hernexeos drug profile — full patent estate, indications, clinical trials, pricing
- Boehringer Ingelheim patent portfolio
- Patent cliff 2026 — 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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