Amaryl generics — when can they launch?
Amaryl (GLIMEPIRIDE) · Sanofi · 4 active US patents · 0 expired
Where Amaryl sits in the generic timeline
Imminent generic cliff: earliest active US patent for Amaryl expires in 2027 (~1 year 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.
- Formulation — 4 patents
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Amaryl drug page →
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This patent protects a solid preparation that combines an insulin sensitizer, an insulin secretagogue, and a polyoxyethylene sorbitan fatty acid ester.USPTO title: Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester
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This patent protects a solid preparation that combines an insulin sensitizer, an insulin secretagogue, and a polyoxyethylene sorbitan fatty acid ester.USPTO title: Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester
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This patent protects a solid preparation containing an insulin sensitizer and another active ingredient, with a specific coating to improve dissolution behavior.USPTO title: Solid preparation
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This patent protects a solid preparation containing an insulin sensitizer and another active ingredient, with a specific coating to improve dissolution behavior.USPTO title: Solid preparation
Sources
- FDA Orange Book — patents listed against Amaryl (NDA filed 1995)
- Amaryl drug profile — full patent estate, indications, clinical trials, pricing
- Sanofi patent portfolio
- Patent cliff 2027 — 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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