Inlyta generics — when can they launch?
Inlyta (Axitinib) · Pfizer · 16 active US patents · 0 expired
Where Inlyta sits in the generic timeline
Mid-term cliff: earliest active US patent for Inlyta expires in 2030 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 8 patents
- Method of Use — 6 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Inlyta 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-2844 | (no description) |
U-4411 | (no description) |
U-3044 | (no description) |
Sample patent estate
Showing 6 of 16 active US patents. View full estate on the Inlyta drug page →
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This patent protects crystalline and amorphous forms of the molecule 6-[2-(methylcarbamoyl)phenyl sulfanyl]-3-E-[2-(pyridin-2-yl)ethenyl]indazole.USPTO title: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
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This patent protects crystalline and amorphous forms of the molecule 6-[2-(methylcarbamoyl)phenyl sulfanyl]-3-E-[2-(pyridin-2-yl)ethenyl]indazole.USPTO title: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
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This patent protects crystalline forms of a specific indazole compound suitable for treating abnormal cell growth in mammals.USPTO title: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
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This patent protects crystalline forms of a specific indazole compound suitable for treating abnormal cell growth in mammals.USPTO title: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
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This patent protects the use of a combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer, particularly cancers that express PD-L1.USPTO title: Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
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This patent protects the use of a combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer, particularly cancers that express PD-L1.USPTO title: Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
Sources
- FDA Orange Book — patents listed against Inlyta (NDA filed 2012)
- Inlyta drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2030 — 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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