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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Odevixibat has one hundred and twenty-two patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for odevixibat

International Patents:	122
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	4
Patent Applications:	174
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	215498-001	Jul 20, 2021		RX	Yes	No
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

Expired US Patents for odevixibat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	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/004691 Bylvay 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
Lithuania	3023102
Philippines	12020552165	PHARMACEUTICAL FORMULATION OF ODEVIXIBAT
Slovenia	3400944

Supplementary Protection Certificates for odevixibat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	2021054	Norway		PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1566 20210805
3400944	301157	Netherlands		PRODUCT NAME: ODEVIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1566 20210719
3400944	LUC00242	Luxembourg		PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719

Market Dynamics and Financial Trajectory for Odevixibat

Last updated: July 5, 2025

Introduction

Odevixibat, a bile acid modulator developed by Albireo Pharma and now under Ipsen, targets pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) and other cholestatic liver diseases. As rare disease treatments gain prominence, this drug exemplifies how targeted therapies can disrupt niche markets while navigating complex regulatory and financial landscapes. Investors and executives must understand its market dynamics and financial path to assess its potential returns and risks.

Overview of Odevixibat

Odevixibat operates as an ileal bile acid transporter (IBAT) inhibitor, reducing bile acid recirculation to alleviate itching and liver damage in PFIC patients. The U.S. Food and Drug Administration (FDA) approved it in July 2021 under the brand name Bylvay for PFIC patients aged three months and older. Europe followed with approvals in 2022, expanding its reach through the European Medicines Agency (EMA). Ipsen's 2021 acquisition of Albireo for $910 million underscores the drug's strategic value, integrating it into a broader portfolio of oncology and rare disease therapies.

This drug addresses a critical unmet need in pediatric hepatology, where PFIC affects roughly 1 in 50,000 to 100,000 live births globally. Clinical trials, including the pivotal Phase 3 study, demonstrated significant reductions in serum bile acids and pruritus scores, positioning odevixibat as a first-line oral treatment. However, its high pricing—around $300,000 annually per patient in the U.S.—reflects the challenges of rare disease economics, where small patient pools demand premium valuations.

Market Dynamics of Odevixibat

The rare disease market for cholestatic liver disorders is expanding rapidly, driven by increased awareness and advanced diagnostics. Odevixibat operates in a niche segment valued at approximately $1.5 billion in 2023, with projections to reach $2.8 billion by 2030 at a compound annual growth rate (CAGR) of 9.5%, according to industry analyses.

Key growth drivers include rising PFIC diagnoses, fueled by genetic screening advancements, and a global shift toward orphan drug designations. The FDA's Orphan Drug status for odevixibat grants seven years of market exclusivity in the U.S., shielding it from generic competition until at least 2028. In Europe, similar protections extend through 2033, bolstering Ipsen's market position.

Competition remains limited but intensifying. Mirum Pharmaceuticals' Livmarli, another IBAT inhibitor for Alagille syndrome and PFIC, directly challenges odevixibat with comparable efficacy. Albireo's earlier lead in development gave odevixibat a first-mover advantage, but emerging players like Cycle Pharmaceuticals could introduce biosimilars post-patent expiry. Regulatory hurdles, such as the FDA's post-marketing commitments for long-term safety data, add complexity, potentially delaying expansions into biliary atresia or other indications.

Geographically, North America dominates with over 60% of global revenue, driven by robust reimbursement policies and high healthcare spending. Europe follows, though price negotiations in countries like Germany and the UK could cap growth. Emerging markets in Asia-Pacific, particularly China and India, offer untapped potential as healthcare infrastructure improves, but intellectual property enforcement remains a barrier.

Patent dynamics further shape the market. Odevixibat's core patents, filed by Albireo in 2010 and granted in major jurisdictions, extend protection until 2030-2035, depending on extensions. Ipsen must defend these vigorously against potential challenges, as generic entrants could erode margins post-exclusivity. Strategic partnerships, such as Ipsen's collaborations with patient advocacy groups, enhance market access by addressing payer concerns and accelerating adoption.

Financial Trajectory of Odevixibat

Odevixibat's financial performance reflects the volatility of rare disease investments. Since its launch, global sales reached approximately $50 million in 2023, up from $20 million in 2022, according to Ipsen's annual reports. This growth stems from expanded indications and market penetration, with U.S. revenues comprising 75% of total sales.

Ipsen's acquisition of Albireo propelled odevixibat into a larger ecosystem, contributing to the parent company's 2023 revenue of €12.5 billion. Analysts forecast odevixibat's sales to climb to $200 million by 2026, driven by label expansions and pediatric demand. Evaluate Pharma estimates a net present value of $1.2 billion for the drug, factoring in peak sales potential and royalty streams.

Funding and partnerships underpin this trajectory. Ipsen's $1.9 billion R&D budget in 2023 supports ongoing trials, including Phase 3 studies for biliary atresia, which could double the addressable market. However, financial risks loom large: pricing pressures from U.S. payers and potential rebates could reduce net revenues by 20-30%. Stock analysts at Bloomberg note that Ipsen's shares rose 15% post-approval, but recent fluctuations tie to broader biotech sentiment and inflation impacts.

Cost structures reveal efficiencies, with manufacturing costs at 25% of sales, allowing healthy margins. Yet, external factors like supply chain disruptions for active ingredients threaten profitability. Long-term, odevixibat could generate $500 million in annual revenue by 2030 if trials succeed, positioning Ipsen for dividends or further acquisitions. Investors should monitor quarterly earnings, as odevixibat accounts for 5-10% of Ipsen's portfolio value.

Future Outlook

Looking ahead, odevixibat's trajectory hinges on clinical advancements and market adaptation. Successful biliary atresia trials could expand the patient base by 50%, boosting revenues amid a growing rare disease focus. However, patent cliffs and biosimilar threats post-2030 demand proactive strategies, such as lifecycle management or combination therapies.

Global economic shifts, including post-pandemic recovery, will influence payer dynamics and drug pricing. Ipsen's diversification into neuroscience and oncology mitigates risks, but odevixibat remains a key growth driver. Stakeholders must watch regulatory decisions in key markets, as they could accelerate or hinder adoption.

Key Takeaways

• Odevixibat leads the PFIC treatment market with strong regulatory protections and projected sales growth to $200 million by 2026.
• Market dynamics favor expansion in North America and Europe, though competition and patent expirations pose risks.
• Financially, the drug enhances Ipsen's revenue stream but faces pricing and supply challenges that could impact margins.
• Strategic partnerships and R&D investments will determine long-term success in a niche but lucrative segment.
• Investors should prioritize monitoring clinical trial outcomes and intellectual property defenses for informed decisions.

FAQs

1. What makes odevixibat unique in the cholestatic liver disease market?
Odevixibat stands out as an oral IBAT inhibitor with proven efficacy in reducing pruritus for PFIC patients, offering a non-invasive alternative to surgical options and securing orphan drug exclusivity.

2. How does odevixibat's pricing affect its financial performance?
At around $300,000 per year, its premium pricing drives high revenues in small patient populations but invites scrutiny from payers, potentially leading to rebates that erode net profits.

3. What are the main competitors to odevixibat?
Primary competitors include Mirum's Livmarli, which targets similar indications, and potential biosimilars that could emerge after patent expiry, intensifying market pressure.

4. How might patent expirations impact odevixibat's trajectory?
Expirations around 2030-2035 could introduce generics, reducing market share unless Ipsen pursues extensions or new formulations to maintain dominance.

5. What factors could drive future revenue growth for odevixibat?
Expansion into additional indications like biliary atresia and improved global access through partnerships could significantly increase patient numbers and revenue streams.

Sources

1. Ipsen Annual Report 2023. Available at: Ipsen corporate website.
2. Evaluate Pharma analysis on rare disease market forecasts, accessed via Bloomberg Terminal.
3. FDA approval documents for Bylvay (odevixibat), July 2021.