Bylvay generics — when can they launch?
Bylvay (ODEVIXIBAT) · Ipsen · 64 active US patents · 0 expired
Where Bylvay sits in the generic timeline
Mid-term cliff: earliest active US patent for Bylvay expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 48 patents
- Composition of Matter — 8 patents
- Formulation — 8 patents
FDA U-codes carved out by Bylvay 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-3186 | (no description) |
U-3648 | (no description) |
U-3187 | (no description) |
Sample patent estate
Showing 6 of 64 active US patents. View full estate on the Bylvay drug page →
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This patent protects specific IBAT inhibitors for the treatment of liver diseases, including their compositions, methods of treatment, and kits.USPTO title: IBAT inhibitors for the treatment of liver diseases
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This patent protects specific IBAT inhibitors for use in the prophylaxis and/or treatment of liver diseases.USPTO title: IBAT inhibitors for the treatment of liver diseases
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This patent protects specific IBAT inhibitors for use in the prophylaxis and/or treatment of liver diseases.USPTO title: IBAT inhibitors for the treatment of liver diseases
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This patent protects specific IBAT inhibitors for use in treating liver diseases.USPTO title: IBAT inhibitors for the treatment of liver diseases
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This patent protects specific IBAT inhibitors for the treatment of liver diseases, including their compositions, methods of treatment, and kits.USPTO title: IBAT inhibitors for the treatment of liver diseases
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This patent protects specific IBAT inhibitors for use in the prophylaxis and/or treatment of liver disease.USPTO title: IBAT inhibitors for the treatment of liver disease
Sources
- FDA Orange Book — patents listed against Bylvay (NDA filed 2021)
- Bylvay drug profile — full patent estate, indications, clinical trials, pricing
- Ipsen patent portfolio
- Patent cliff 2031 — 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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