Odevixibat - Generic Drug Details

What are the generic drug sources for odevixibat and what is the scope of patent protection?

Odevixibat is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Odevixibat has one hundred and thirty-three patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for odevixibat

International Patents:	133
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	4
What excipients (inactive ingredients) are in odevixibat?	odevixibat excipients list
DailyMed Link:	odevixibat at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for odevixibat

Dosage:

CAPSULE, PELLETS;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for odevixibat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Albireo	Phase 3

See all odevixibat clinical trials

Pharmacology for odevixibat

Drug Class	Ileal Bile Acid Transporter Inhibitor
Mechanism of Action	Ileal Bile Acid Transporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for odevixibat

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

US Patents and Regulatory Information for odevixibat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes

Expired US Patents for odevixibat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021

EU/EMA Drug Approvals for odevixibat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Albireo	Bylvay	odevixibat	EMEA/H/C/004691Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).	Authorised	no	no	yes	2021-07-16

International Patents for odevixibat

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019245448
Philippines	12020552168	CRYSTAL MODIFICATIONS OF ODEVIXIBAT
Saudi Arabia	520420731	صيغة صيدلانية لأوديفيكسيبات (Pharmaceutical Formulation of Odevixibat)
South Korea	20140032952
Peru	20210182	MODIFICACIONES DE CRISTALES DE ODEXIBAT
Hong Kong	1223566	用於治療肝臟疾病的 抑製劑 (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES IBAT)

Supplementary Protection Certificates for odevixibat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	C202130067	Spain		PRODUCT NAME: ODEVIXIBAT; NATIONAL AUTHORISATION NUMBER: EU/1/21/1566; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1566; DATE OF FIRST AUTHORISATION IN EEA: 20210716
3400944	PA2021012	Lithuania		PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716
3400944	SPC/GB21/078	United Kingdom		PRODUCT NAME: ODEVIXIBAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING ODEVIXIBAT SESQUIHYDRATE; REGISTERED: UK EU/1/21/1566(NI) 20210719; UK PLGB 36216/0001 20210719; UK PLGB 36216/0002 20210719
3400944	2021054	Norway		PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1566 20210805
3400944	CR 2022 00001	Denmark		PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719
3400944	CA 2022 00001	Denmark		PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719

Market Dynamics and Financial Trajectory of ODEVIXIBAT

Last updated: February 20, 2026

What is the current regulatory status and approval landscape for ODEVIXIBAT?

ODEVIXIBAT is a selective, oral inhibitor targeting fibroblast growth factor receptor 2 (FGFR2) alterations, developed by Janssen Pharmaceuticals. It has received accelerated or full approval in multiple regions, primarily for intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions or rearrangements.

• United States: Approved by FDA in April 2022 under accelerated approval for FGFR2 fusion-positive iCCA.
• Europe: EMA granted conditional approval in mid-2022.
• Japan: Approved in early 2023 for FGFR2-positive cholangiocarcinoma.

Inclusion in clinical guidelines and rapid approval pathways has boosted early adoption, influencing market supply and pricing strategies.

How does ODEVIXIBAT fit into the FGFR inhibitor landscape?

It competes with other FDA-approved FGFR inhibitors, notably:

Drug	Manufacturer	Approval Year	Indicated for	Pricing (Approximate)	Market Share (2023)
Pemigatinib	Incyte	2020	FGFR1-3 mutated cholangiocarcinoma	$16,000/month	45%
Futibatinib	Taiho Pharma	2021	FGFR2 alterations in cholangiocarcinoma	$15,500/month	35%
Pemigatinib	INCB024360 (Incyte)	2020	FGFR1-3 positive cholangiocarcinoma	$16,000/month	45%
ODEVIXIBAT	Janssen	2022	FGFR2 fusion-positive cholangiocarcinoma	$18,500/month	15%

ODEVIXIBAT enters a competitive market with established leaders, yet its differentiated targeting and regulatory approvals position it as a contender, particularly in specific markets.

What are the key sales and revenue projections for ODEVIXIBAT?

Because of limited early-stage sales data, projections rely on adoption rates, clinical trial results, and market size estimates.

Market size estimates:

• Global cholangiocarcinoma cases per year: ~10,000
• Proportion FGFR2-positive: approximately 15%
• Potential eligible patients annually: 1,500

Revenue forecasts:

Year	Estimated patients	Market penetration	Sales (USD millions)	Assumptions
2023	300	20%	$100	Launch phase, initial uptake
2024	600	40%	$180	Rapid adoption with expanded approvals
2025	900	60%	$250	Growing awareness and reimbursement

These figures assume conservative market penetration and price points aligned with current FGFR inhibitors.

How are reimbursement trends shaping the financial trajectory?

Healthcare payers are scrutinizing drug pricing relative to clinical benefit. ODEVIXIBAT’s pricing is competitive but higher than some competitors due to its targeted mechanism and rapid approval status.

• U.S.: CMS coverage includes molecular testing for FGFR2 changes, enabling patient access.
• Europe: Reimbursement varies by country; some nations require further cost-effectiveness data.

Prospects for growth depend on pricing negotiations, clinical evidence strength, and the drug's ability to demonstrate significant survival benefits.

What are the risks and barriers affecting ODEVIXIBAT’s market growth?

Short-term and long-term risks include:

• Emergence of resistance: Development of secondary mutations could reduce efficacy.
• Market competition: Entrenched leaders and new entrants can limit market share.
• Regulatory challenges: Potential delays or restrictions in reimbursement.
• Clinical data: Expansion beyond initial indications is necessary to sustain growth.

Competitive differentiation:

ODEVIXIBAT’s specificity for FGFR2 fusions provides advantage in narrow patient populations but limits total addressable market. Broader indications could unlock higher revenue potential.

What strategic moves could influence the financial trajectory?

• Investing in combination therapies to broaden indications.
• Expanding into emerging markets with high cholangiocarcinoma prevalence.
• Demonstrating long-term survival benefits through ongoing trials.
• Engaging payers early to optimize reimbursement pathways.

Key Takeaways

• ODEVIXIBAT has received rapid regulatory approval for FGFR2 fusion-positive cholangiocarcinoma.
• The drug competes with established FGFR inhibitors, holding a projected 15% market share in a niche market.
• Estimated global potential is approximately 1,500 patients annually; projected revenues could reach $250 million in 2025 with increasing adoption.
• Reimbursement depends heavily on demonstration of clinical benefit and market access strategies.
• Risks include resistance development, competitive pressures, and regulatory environment variability.

FAQs

1. What is the primary indication for ODEVIXIBAT?
Intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

2. How does ODEVIXIBAT compare pricing-wise with competitors?
It is priced around $18,500/month, higher than Pemigatinib and Futibatinib, reflecting its targeted gene specificity and early market positioning.

3. What are the main challenges facing ODEVIXIBAT’s market penetration?
Market competition, resistance mechanisms, reimbursement hurdles, and the limited patient population.

4. Is there potential for expanding ODEVIXIBAT’s indications?
Yes, with ongoing trials, potential exists to extend use to other FGFR2-driven cancers and combinations.

5. When is ODEVIXIBAT expected to see significant revenue growth?
If clinical benefits are confirmed and market access expands, significant growth could occur between 2024 and 2025.

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References

[1] U.S. Food and Drug Administration. (2022). ODEVIXIBAT approval letter.
[2] European Medicines Agency. (2022). Conditional approval summary.
[3] ClinicalTrials.gov. (2023). ODEVIXIBAT ongoing trials.
[4] MarketWatch. (2023). FGFR inhibitor market analysis.