Farxiga generics — when can they launch?
Farxiga (DAPAGLIFLOZIN) · AstraZeneca · 144 active US patents · 26 expired
Where Farxiga sits in the generic timeline
All listed Orange Book patents for Farxiga 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 — 72 patents
- Method of Use — 34 patents
- Formulation — 25 patents
- Composition of Matter — 13 patents
FDA U-codes carved out by Farxiga 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-2213 | (no description) |
U-2139 | (no description) |
U-1976 | (no description) |
U-493 | (no description) |
U-1977 | (no description) |
U-1522 | (no description) |
U-3766 | (no description) |
U-4346 | (no description) |
U-3127 | (no description) |
U-3825 | (no description) |
U-4140 | (no description) |
Sample patent estate
Showing 6 of 144 active US patents. View full estate on the Farxiga drug page →
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This patent provides methods for reducing body weight, altering body composition, treating diabetes, and lowering blood glucose levels using exendins or their agonists.USPTO title: Methods for treating diabetes and reducing body weight
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Methods for reducing body weight, altering body composition, treating diabetes, and lowering blood glucose levels using exendins or exendin agonists are provided.USPTO title: Method for treating diabetes
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Methods for reducing body weight, altering body composition, treating diabetes, and lowering blood glucose levels using exendins or exendin agonists are provided.USPTO title: Method for treating diabetes
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This patent provides methods for reducing body weight, altering body composition, treating diabetes, and lowering blood glucose levels using exendins or their agonists.USPTO title: Methods for treating diabetes and reducing body weight
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This patent protects methods for using exendins, exendin agonists, or exendin analog agonists to reduce body weight, alter body composition, treat diabetes, and lower blood glucose levels.USPTO title: Methods for treating diabetes and reducing body weight
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This patent protects methods for using exendins, exendin agonists, or exendin analog agonists to reduce body weight, alter body composition, treat diabetes, and lower blood glucose levels.USPTO title: Methods for treating diabetes and reducing body weight
Sources
- FDA Orange Book — patents listed against Farxiga (NDA filed 2014)
- Farxiga drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca 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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