IBUPROFEN LYSINE generics — when can they launch?
IBUPROFEN LYSINE (IBUPROFEN LYSINE) · · 1 active US patent · 0 expired
Where IBUPROFEN LYSINE sits in the generic timeline
Mid-term cliff: earliest active US patent for IBUPROFEN LYSINE expires in 2032 (~6 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.
- Composition of Matter — 1 patent
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the IBUPROFEN LYSINE drug page →
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This patent protects an improved ibuprofen lysine pharmaceutical composition and a process for preparing it.USPTO title: Ibuprofen compositions and methods of making same
Sources
- FDA Orange Book — patents listed against IBUPROFEN LYSINE (NDA filed 2006)
- IBUPROFEN LYSINE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2032 — 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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