Bevyxxa generics — when can they launch?
Bevyxxa (BETRIXABAN) · Portola Pharms Inc · 10 active US patents · 0 expired
Where Bevyxxa sits in the generic timeline
All listed Orange Book patents for Bevyxxa 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.
- Method of Use — 6 patents
- Composition of Matter — 2 patents
- Formulation — 2 patents
FDA U-codes carved out by Bevyxxa 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-1502 | (no description) |
U-1167 | (no description) |
U-2034 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Bevyxxa drug page →
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This patent protects pharmaceutical salts and polymorphs of a factor Xa inhibitor, specifically compounds with Formula I.USPTO title: Pharmaceutical salts and polymorphs of a factor Xa inhibitor
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This patent protects pharmaceutical salts and polymorphs of a factor Xa inhibitor, specifically compounds with Formula I.USPTO title: Pharmaceutical salts and polymorphs of a factor Xa inhibitor
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This patent protects salts of a compound that inhibits mammalian factor Xa, along with methods of making that compound.USPTO title: Pharmaceutical salts and polymorphs of a factor Xa inhibitor
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This patent protects salts of a compound that inhibits mammalian factor Xa, along with methods of making that compound.USPTO title: Pharmaceutical salts and polymorphs of a factor Xa inhibitor
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This patent protects methods for preventing or treating conditions with undesired thrombosis in mammals using a specific crystalline form of a maleate salt of a factor Xa inhibitor.USPTO title: Methods of using crystalline forms of a salt of a factor Xa inhibitor
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This patent protects methods for preventing or treating thrombosis in mammals using a specific crystalline form of a maleate salt of a factor Xa inhibitor.USPTO title: Methods of using crystalline forms of a salt of a factor Xa inhibitor
Sources
- FDA Orange Book — patents listed against Bevyxxa (NDA filed 2017)
- Bevyxxa drug profile — full patent estate, indications, clinical trials, pricing
- Portola Pharms Inc 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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