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 thirty-two patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for odevixibat

International Patents:	132
US Patents:	13
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

Constraining patent/regulatory exclusivity:

10,975,046

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	11,365,182
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	10,093,697
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	10,975,046			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No	11,801,226		Y

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	7,132,416
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021	7,132,416
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021	7,132,416
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021	7,132,416

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
Brazil	112020024461
Costa Rica	20210027
Luxembourg	C00242
South Korea	20210024032
Malaysia	163275	IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES
Mexico	2020013774	MODIFICACIONES DE CRISTALES DE ODEVIXIBAT. (CRYSTAL MODIFICATIONS OF ODEVIXIBAT.)

Supplementary Protection Certificates for odevixibat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	122021000075	Germany		PRODUCT NAME: ODEVIXIBAT, EINSCHLIESSLICH PHARMAZEUTISCH VERTRAEGLICHER SALZE UND SOLVATE DAVON, INSBESONDERE ODEVIXIBAT-HYDRAT; REGISTRATION NO/DATE: EU/1/21/1566 20210716
3400944	LUC00242	Luxembourg		PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
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	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	PA2021012,C3400944	Lithuania		PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Odevixibat

Last updated: July 27, 2025

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Introduction

Odevixibat emerges as a pioneering therapeutic agent targeting rare cholestatic liver diseases, notably progressive familial intrahepatic cholestasis (PFIC). With its novel mechanism of action and strategic clinical development, odevixibat holds significant potential in niche and potentially broader markets. This report provides an in-depth analysis of the market dynamics influencing odevixibat’s commercial trajectory and examines its financial prospects within the pharmaceutical landscape.

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Overview of Odevixibat

Odevixibat is an oral, selective ileal bile acid transporter (IBAT) inhibitor developed by Albireo Pharma, Inc. It aims to reduce serum bile acids, thereby alleviating symptoms associated with cholestatic diseases, such as pruritus, fat malabsorption, and progressive liver injury. The drug’s regulatory journey includes FDA approval in pediatric PFIC patients, positioning it as a targeted therapy for this ultra-rare condition.

The FDA approval in December 2021 marked a significant milestone, establishing odevixibat as the first approved therapy for PFIC in the United States. The approval, based on compelling phase 3 trial data, highlighted the drug’s safety and efficacy, especially in reducing pruritus and serum bile acid levels.

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Market Dynamics

1. Target Market Dimensions

The primary market for odevixibat initially revolves around pediatric patients with PFIC, a rare genetic disorder characterized by impaired bile flow, leading to severe pruritus, growth retardation, and progressive liver damage. Globally, PFIC prevalence estimates range from 1 in 50,000 to 1 in 100,000 live births, with a higher-fold prevalence in populations with increased consanguinity [1].

However, the niche nature of PFIC constrains the immediate addressable market. Nonetheless, the drug’s potential extends into broader cholestatic disorders, including Alagille syndrome and other pediatric cholestasis syndromes.

2. Competitive Landscape

Odevixibat’s primary competition exists in the form of off-label use of existing bile acid sequestrants (e.g., cholestyramine) and the emerging pipeline of IBAT inhibitors. Notably, Lumena’s maralixibat, another IBAT inhibitor, is under investigation for pediatric cholestasis, hinting at a fragmented competitive environment.

The competitive positioning of odevixibat benefits from its FDA approval and the specialization in PFIC, offering a first-mover advantage in the ultra-rare disease segment.

3. Regulatory and Reimbursement Considerations

Regulatory approvals, including European Medicines Agency (EMA) filings, are critical to market expansion. The orphan drug designation for odevixibat facilitates incentives such as market exclusivity and fee reductions, which bolster financial prospects.

Reimbursement pathways are complex, given the high cost of orphan drugs. Payer willingness to reimburse depends on demonstrable clinical benefit and cost-effectiveness, especially as healthcare systems prioritize resource allocation for ultra-rare conditions.

4. Clinical and Commercial Expansion Potential

Beyond PFIC, odevixibat’s mechanism suggests potential in other cholestatic conditions, such as Alagille syndrome, primary sclerosing cholangitis, and adult cholestasis. Phase 2 clinical trials are ongoing for some indications, which could significantly widen the drug’s market footprint if successful.

Moreover, off-label use and physician familiarity with IBAT inhibitors could facilitate early market penetration in related pediatric cholestatic disorders.

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Financial Trajectory

1. Revenue Streams and Sales Potential

Albireo Pharma projects revenues primarily from odevixibat’s commercial sales within the United States and Europe. Initial sales are expected to be modest, reflecting the ultra-rare disease focus, but growth prospects depend on:

• Market penetration rates among pediatric specialists and hepatologists.
• Adoption in off-label uses and additional indications.
• Pricing strategies aligned with orphan drug policies, often in the range of $200,000 to $500,000 per patient annually [2].

In the immediate term, sales are likely to be constrained by the limited patient population, but multiple lines of revenue could emerge from adjunctive therapies or pipeline expansion.

2. Cost Structure and Investment

Development costs for odevixibat amounted to hundreds of millions, covering clinical trials, regulatory filings, and commercialization preparations. Ongoing costs include manufacturing scale-up, post-approval studies, and marketing.

Albireo's financial health indicates significant investments with the anticipation of accelerated sales growth driven by expanded indications and geographic expansion.

3. Market Penetration and Revenue Growth Trajectory

Given the rarity of PFIC, initial revenue estimates for 2023-2024 may range between $10 million and $50 million, depending on geographic uptake and payer access.

As awareness increases and healthcare providers adopt odevixibat, revenues could approach $200 million annually within five years, especially if clinical success unlocks broader indications.

4. Valuation and Investment Outlook

Albireo’s valuation reflects its pipeline potential, recent approvals, and market positioning. The company’s strategic focus on rare diseases and orphan drug exclusivity enhances expected revenue durability.

Investors closely monitor clinical trial outcomes for wider indications; successful phase 2/3 data could trigger significant valuation re-ratings.

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Market Challenges and Opportunities

Challenges:

• Limited patient populations constrain revenue volumes.
• High drug costs may face reimbursement hurdles or payer resistance.
• Emerging competition from other IBAT inhibitors and future pipeline entrants.
• Regulatory barriers for expanding into adult cholestatic diseases.

Opportunities:

• Expansion into additional pediatric and adult cholestatic disorders.
• Strategic partnerships with healthcare providers for early adoption.
• Potential for orphan drug exclusivity reinforcement and label expansions.
• Novel combination therapies addressing complex cholestatic pathologies.

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Conclusion

Odevixibat stands at a pivotal juncture in its commercial lifecycle. Its market dynamics are shaped by the ultra-rare disease focus, regulatory milestones, and clinical efficacy. While immediate revenues are modest, the drug’s long-term potential hinges on clinical success in broader indications, geographic expansion, and payer acceptance.

The financial trajectory, although constrained by the size of its initial market, appears promising given the unmet need, pricing potential, and orphan drug incentives. Strategic positioning, evidence generation, and effective stakeholder engagement will be key to maximizing its commercial impact.

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Key Takeaways

• Initial Success in PFIC sets the stage for future growth; late 2020s expansion is contingent on broader indications’ approval.
• Market size remains limited but offers lucrative opportunities given high per-patient pricing and strong unmet need.
• Competition exists but is countered by early regulatory approval and specialization.
• Reimbursement and health policy strategies will influence revenue realization.
• Clinical development in related cholestatic conditions could exponentially increase odevixibat’s market footprint.

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FAQs

Q1: What is the primary therapeutic target of odevixibat?
A: Odevixibat targets the ileal bile acid transporter (IBAT), reducing serum bile acids in cholestatic liver diseases.

Q2: How significant is the PFIC market for odevixibat?
A: Given the rarity of PFIC, the initial market size is small but strategically important, with estimates of fewer than 10,000 patients worldwide.

Q3: What are the main hurdles for odevixibat’s commercial success?
A: Challenges include limited patient population, high treatment costs, payer reimbursement issues, and competition from other IBAT inhibitors.

Q4: Can odevixibat’s market extend beyond pediatric PFIC?
A: Yes, ongoing trials aim to evaluate its efficacy in pediatric and adult cholestatic disorders such as Alagille syndrome and primary sclerosing cholangitis.

Q5: How does orphan drug status influence odevixibat’s financial prospects?
A: Orphan designation confers up to 7 years of market exclusivity in the US, incentivizing sales and attracting investment by reducing competitive pressures.

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References

[1] European Medicines Agency. “Progressive familial intrahepatic cholestasis (PFIC).” EMA, 2022.
[2] EvaluatePharma. “Orphan Drug Pricing and Market Analysis.” 2022.