Prilosec generics — when can they launch?
Prilosec (omeprazole) · AstraZeneca (originally Astra AB) · 10 active US patents · 0 expired
Where Prilosec sits in the generic timeline
Long-dated protection: earliest active US patent for Prilosec extends to 2036 (~11 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 — 8 patents
- Method of Use — 2 patents
FDA U-codes carved out by Prilosec 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-623 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Prilosec drug page →
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This patent protects stable orally disintegrating tablets containing a proton pump inhibitor, such as those used to treat conditions treated by Prilosec.USPTO title: Stable orally disintegrating pharmaceutical compositions
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This patent protects stable orally disintegrating tablets containing a proton pump inhibitor, such as those used to treat conditions treated by Prilosec.USPTO title: Stable orally disintegrating pharmaceutical compositions
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This patent protects liquid diluents, formulations, and kits for preparing reconstituted suspensions of omeprazole, a proton pump inhibitor.USPTO title: Compositions and kits for omeprazole suspension
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This patent protects liquid diluents, formulations, and kits for preparing reconstituted suspensions of omeprazole, a proton pump inhibitor.USPTO title: Compositions and kits for Omeprazole suspension
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This patent protects liquid diluents, formulations, and kits for preparing reconstituted suspensions of omeprazole, a proton pump inhibitor.USPTO title: Compositions and kits for Omeprazole suspension
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This patent protects liquid diluents, formulations, and kits for preparing reconstituted suspensions of omeprazole, a proton pump inhibitor.USPTO title: Compositions and kits for omeprazole suspension
Sources
- FDA Orange Book — patents listed against Prilosec (NDA filed 1989)
- Prilosec drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca (originally Astra AB) 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.
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