Prevacid generics — when can they launch?
Prevacid (lansoprazole) · Generic (originally Takeda) · 2 active US patents · 0 expired
Where Prevacid sits in the generic timeline
Long-dated protection: earliest active US patent for Prevacid extends to 2036 (~10 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Prevacid drug page →
-
This patent protects an orally disintegrating dosage form of a proton pump inhibitor, such as Prevacid, that rapidly disintegrates in the oral cavity after administration.USPTO title: Orally disintegrating compositions
-
This patent protects an orally disintegrating dosage form of a proton pump inhibitor, such as Prevacid, that rapidly disintegrates in the oral cavity after administration.USPTO title: Orally disintegrating compositions
Sources
- FDA Orange Book — patents listed against Prevacid (NDA filed 1995)
- Prevacid drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Takeda) patent portfolio
- Patent cliff 2036 — 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.
Get generic entry alerts
Free Pharma CI alerts on Prevacid — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →