Nilotinib Hydrochloride generics — when can they launch?
Nilotinib Hydrochloride (Nilotinib Hydrochloride) · Jan Beumer · 36 active US patents · 0 expired
Where Nilotinib Hydrochloride sits in the generic timeline
All listed Orange Book patents for Nilotinib Hydrochloride 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.
- Other — 18 patents
- Method of Use — 9 patents
- Formulation — 6 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Nilotinib Hydrochloride 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-1374 | (no description) |
U-1407 | (no description) |
Sample patent estate
Showing 6 of 36 active US patents. View full estate on the Nilotinib Hydrochloride drug page →
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This patent protects a method of preparing salts of a specific chemical compound.USPTO title: Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
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This patent protects crystalline forms of the free base and salts of a specific compound used in the preparation of Nilotinib Hydrochloride.USPTO title: Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
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This patent protects a method of preparing salts of a specific chemical compound.USPTO title: Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
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This patent protects a pharmaceutical composition, specifically capsules, containing nilotinib or its salt with one or more acceptable excipients.USPTO title: Pharmaceutical compositions comprising nilotinib or its salt
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This patent protects a pharmaceutical composition, specifically capsules, containing nilotinib or its salt with one or more acceptable excipients.USPTO title: Pharmaceutical compositions comprising nilotinib or its salt
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This patent protects a pharmaceutical composition, specifically capsules, containing nilotinib or its salt with one or more acceptable excipients.USPTO title: Pharmaceutical compositions comprising nilotinib or its salt
Sources
- FDA Orange Book — patents listed against Nilotinib Hydrochloride (NDA)
- Nilotinib Hydrochloride drug profile — full patent estate, indications, clinical trials, pricing
- Jan Beumer 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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