BYLVAY Drug Patent Profile

When do Bylvay patents expire, and when can generic versions of Bylvay launch?

Bylvay is a drug marketed by Ipsen and is included in one NDA. There are fifteen patents protecting this drug.

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

The generic ingredient in BYLVAY is odevixibat. Two suppliers are listed for this compound. Additional details are available on the odevixibat profile page.

DrugPatentWatch^® Generic Entry Outlook for Bylvay

Bylvay was eligible for patent challenges on July 20, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 20, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BYLVAY

International Patents:	133
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	15
Drug Prices:	Drug price information for BYLVAY
What excipients (inactive ingredients) are in BYLVAY?	BYLVAY excipients list
DailyMed Link:	BYLVAY at DailyMed

See drug prices for BYLVAY

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

NDA:

215498

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.

Pharmacology for BYLVAY

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

US Patents and Regulatory Information for BYLVAY

BYLVAY is protected by twenty-six US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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;ORAL	215498-002	Jul 20, 2021		RX	Yes	No			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes				Y
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				Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No

Expired US Patents for BYLVAY

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 BYLVAY

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 BYLVAY

When does loss-of-exclusivity occur for BYLVAY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Ecuador

European Patent Office

Finland

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Nicaragua

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYLVAY around the world.

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
Hungary	E030062
Peru	20210182	MODIFICACIONES DE CRISTALES DE ODEXIBAT

Supplementary Protection Certificates for BYLVAY

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 for BYLVAY

Last updated: February 20, 2026

What is BYLVAY?

BYLVAY (nedosiran) is a gene-silencing therapy developed by Reneo Pharmaceuticals for the treatment of primary hyperoxaluria (PH), a rare genetic disorder that causes excessive oxalate production leading to kidney stones, nephropathy, and kidney failure. Approved by the U.S. Food and Drug Administration (FDA) in August 2022, BYLVAY aims to reduce urinary oxalate levels by inhibiting hepatic lactate dehydrogenase (LDH), the enzyme involved in oxalate synthesis.

How does BYLVAY position within the rare disease market?

Primary hyperoxaluria (PH) is an ultra-rare, inherited metabolic disorder with an estimated prevalence of 1 to 3 cases per million population globally. The absence of approved pharmacological treatments prior to BYLVAY positions this therapy as a potentially groundbreaking intervention.

Market size and unmet need

Parameter	Data
Prevalence of PH	1-3 per million
Estimated patient population (US)	2,000 - 6,000 (total global)
Current standard of care	Surgical intervention, renal transplant
Market under treatment	Limited, with no approved pharmacotherapy

Key competitors

• Lumasiran (Oxluma, Alnylam): Approved for Primary Hyperoxaluria Type 1 (PH1) in 2020.
• Calliditas’ Nefecon: Under investigation for other kidney-related conditions but not directly competing.
• Emerging gene therapies: Several startups developing gene editing approaches for rare metabolic disorders.

How does BYLVAY’s approval influence its market trajectory?

BYLVAY's FDA approval positions it as the first pharmacological agent targeting the underlying mechanism of PH. It introduces an entirely new treatment paradigm that could replace or delay invasive procedures like dialysis or kidney transplants.

Market penetration prospects

• Initial adoption: Limited to specialized nephrology and rare disease centers in the U.S.
• Pricing assumptions: Estimated at $300,000 to $500,000 annually per patient based on comparable orphan drugs.
• Reimbursement landscape: Likely to face insurance hurdles initially, but payers may accept it given the high cost and limited alternatives for PH.

Market growth estimates

Year	Estimated Global Patient Population	Expected Growth Factors	Market Revenue Projection (USD)
2022	2,000	Market entry, initial uptake	$50 million (initial sales)
2023	2,500	Increased awareness, expanded indications	$150 million
2024	3,000	Broader payer coverage, increased prescribing	$300 million
2025+	4,000+	Expansion to other indications, longer-term adoption	$500+ million

Drivers supporting market expansion

• Expanding indications: Potential for use in other oxalate-related disorders.
• Patient identification: Advances in genetic diagnosis will improve patient detection.
• Pricing negotiations: Payers’ willingness to reimburse could influence revenue.

Financial outlook and commercialization

Reneo forecasts that BYLVAY will generate peak sales between $500 million and $1 billion by the late 2020s, assuming successful market adoption and expansion. The company’s 2022 filings show a substantial investment in manufacturing scale-up and global regulatory submissions, including in Europe and Japan.

Revenue pipeline

Year	Sales Estimate	Major Milestones
2022	$50 million	U.S. launch
2023	$150 million	Expansion to additional regions
2024	$300 million	Additional regulatory approvals
2025+	$500 million - $1 billion	Uptake in broader patient segments

Cost considerations

• Manufacturing scale-up costs due to biologic complexity.
• Investment in clinical studies to expand indications.
• Expansion expenses for global commercialization.

Challenges and risks

• Pricing and reimbursement: Negotiations could limit profitability if reimbursement is lower than expected.
• Market penetration: Small patient population may constrain rapid sales growth.
• Competition: Development of alternative gene therapies or small molecules could erode market share.
• Regulatory hurdles: Delays in approval in key markets could impact revenue.

Key Takeaways

• BYLVAY's FDA approval introduces a first-in-class therapy for primary hyperoxaluria reducing the annual treatment cost estimate to hundreds of thousands of dollars.
• The rare disease nature yields a small total addressable market, but high unmet need enhances revenue potential.
• Early market adoption relies heavily on specialist awareness, reimbursement negotiations, and demonstration of long-term benefits.
• Revenue growth is projected to accelerate over the next 2-3 years with regional expansion and indication diversification.
• Manufacturing complexities and competitive threats could influence long-term financial success.

FAQs

Q1: What are the primary advantages of BYLVAY over existing treatment options?

BYLVAY targets the disease's underlying enzyme, reducing oxalate production. It can lower urinary oxalate levels proactively, potentially delaying or avoiding invasive procedures like kidney transplants, unlike current supportive treatments.

Q2: What are the barriers to market penetration for BYLVAY?

The small patient population, high treatment costs, and reimbursement challenges serve as primary barriers. Specialist awareness and genetic testing capabilities also influence uptake.

Q3: How does BYLVAY compare pricing-wise to similar orphan drugs?

Estimated annual costs range from $300,000 to $500,000 per patient, aligning with drugs like Vertex’s Orkambi or Alnylam’s multiple myeloma therapies. Pricing reflects the rarity, value proposition, and treatment costs for the disease.

Q4: What is the potential for BYLVAY beyond primary hyperoxaluria?

Potential exists for use in related oxalate-related nephropathies if clinical evidence supports efficacy. Development of related formulations or combination therapies could expand its use.

Q5: What are the key risks associated with BYLVAY’s commercial success?

Market size limitations, reimbursement hurdles, competition from emerging therapies, and manufacturing complexities pose potential risks. Resistance or variable patient responses may also impact long-term efficacy perceptions.

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References

1. Reneo Pharmaceuticals. (2022). BYLVAY (nedosiran) prescribing information. FDA.
2. U.S. Food and Drug Administration. (2022). FDA approves first therapy for primary hyperoxaluria. FDA News Release.
3. Alnylam Pharmaceuticals. (2020). Oxluma (lumasiran) approval details. [Corporate Press Release].
4. European Medicines Agency. (2022). Regulatory filings for BYLVAY. EMA approval documents.