Dexilant generics — when can they launch?
Dexilant (DEXLANSOPRAZOLE) · Takeda · 22 active US patents · 9 expired
Where Dexilant sits in the generic timeline
All listed Orange Book patents for Dexilant have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 10 patents
- Formulation — 8 patents
- Method of Use — 4 patents
FDA U-codes carved out by Dexilant 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-951 | (no description) |
U-1805 | (no description) |
Sample patent estate
Showing 6 of 22 active US patents. View full estate on the Dexilant drug page →
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This patent protects dosage forms of a proton pump inhibitor (PPI) that release two doses, each raising plasma levels to at least 100 ng/ml.USPTO title: Multiple PPI dosage form
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This patent protects dosage forms of a proton pump inhibitor (PPI) that release two doses, each raising plasma levels to at least 100 ng/ml.USPTO title: Multiple PPI dosage form
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This patent protects dosage forms of a proton pump inhibitor (PPI) that release two doses, each raising plasma levels to at least 100 ng/ml.USPTO title: Multiple PPI dosage form
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This patent protects a controlled release preparation that slowly releases an active ingredient in the gastrointestinal tract for an extended period of time.USPTO title: Controlled release preparation
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This patent protects a controlled release preparation that slowly releases an active ingredient in the gastrointestinal tract for an extended period of time.USPTO title: Controlled release preparation
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This patent protects a formulation of granules containing a high concentration of an acid-unstable medicament, specifically a benzimidazole compound.USPTO title: Granules containing acid-unstable chemical in large amount
Sources
- FDA Orange Book — patents listed against Dexilant (NDA filed 2009)
- Dexilant drug profile — full patent estate, indications, clinical trials, pricing
- Takeda patent portfolio
- Patent cliff 2026 — 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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