Prescription medicine
Odevixibat Brand names: Bylvay
Odevixibat (Bylvay) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the odevixibat FDA label on DailyMed (effective December 29, 2025, Ipsen Biopharmaceuticals, Inc.); the NDA 215498 record on Drugs@FDA; every odevixibat label on DailyMed.
Highlights of the record
FDA label of December 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
Forms and strengths
Capsule; capsule (coated pellets).
On the market
- Earliest approval on file
- July 20, 2021 Bylvay, Ipsen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 12, 2041 Bylvay capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 350 through July 30, 2026
What is odevixibat used for?
From the label: indications and usageBYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.1 ) Limitation of Use: BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. ( 12.5 , 14.1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS). […]
FDA pharmacologic class: Ileal Bile Acid Transporter Inhibitor.
Source: FDA drug label (Bylvay), Ipsen Biopharmaceuticals, Inc., effective December 29, 2025 (SPL set 0935cd31-3251-4a0a-ac23-25ca4be12be9), via openFDA; the full label on DailyMed
Is there a generic for odevixibat (Bylvay)?
No generic odevixibat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 16 patents for Bylvay capsules: the compound patent runs to June 20, 2039, and the last listed entry to November 12, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the odevixibat label say about other medicines?
The odevixibat label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | DRUG INTERACTIONS 7.1 Bile Acid Binding Resins Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of BYLVAY [see Dosage and Administration (2.3) ]. |
| Colesevelam | drug interactions | DRUG INTERACTIONS 7.1 Bile Acid Binding Resins Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of BYLVAY [see Dosage and Administration (2.3) ]. |
| Colestipol | drug interactions | DRUG INTERACTIONS 7.1 Bile Acid Binding Resins Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of BYLVAY [see Dosage and Administration (2.3) ]. |
| Vitamin a | warnings and precautions | FSV include vitamin A, D, E, and K (measured using INR levels). |
Source: FDA drug label (Bylvay), Ipsen Biopharmaceuticals, Inc., effective December 29, 2025 (SPL set 0935cd31-3251-4a0a-ac23-25ca4be12be9), via openFDA; the full label on DailyMed
What do FAERS reports show for odevixibat?
The FDA Adverse Event Reporting System holds 350 reports that list odevixibat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 67 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other ileal bile acid transporter inhibitors
- the pharmacologic class, with prices and generics
- Odevixibat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other