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 thirteen patents protecting this drug.

This drug has one hundred and thirty-two 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:	132
US Patents:	13
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

Constraining patent/regulatory exclusivity:

10,975,046

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-three US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,975,046.

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	215498-004	Jul 20, 2021		RX	Yes	Yes	11,801,226		Y
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,093,697
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes	10,093,697
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,975,046			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No	9,694,018

Expired US Patents for BYLVAY

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 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
South Korea	20040036935
Brazil	112020024461
Russian Federation	2591188	ИНГИБИТОРЫ IBAT ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ ПЕЧЕНИ (IBAT INHIBITOR FOR TREATING HEPATIC DISORDERS)
Costa Rica	20210027
United Kingdom	0121768

Supplementary Protection Certificates for BYLVAY

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BYLVAY

Last updated: July 27, 2025

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Introduction

BYLVAY (doravirine) represents a novel antiviral agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 infection. With the global HIV therapeutic market valued at approximately USD 21 billion in 2022 and projected growth driven by increasing prevalence and therapeutic innovations, understanding BYLVAY’s market dynamics and financial trajectory is crucial for stakeholders. This analysis explores the factors influencing BYLVAY’s market position, competitive landscape, revenue potential, and strategic outlook.

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Market Overview and Therapeutic Context

The global HIV treatment market is marked by rapid developments in antiretroviral therapies (ART), with newer agents offering improved efficacy, safety profiles, and administration convenience. While first-generation drugs such as efavirenz and lamivudine pioneered HIV management, recent advancements focus on integrase inhibitors and next-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs), including doravirine.

BYLVAY’s emergence as an NNRTI offers benefits such as reduced drug-drug interactions, improved tolerability, and simplified dosing, positioning it as a competitive option within the evolving ART landscape. The steady rise in HIV prevalence globally—estimated at 38 million people living with HIV in 2022—ensures ongoing demand for effective, tolerable, and easy-to-administer therapies.

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Market Dynamics

1. Competitive Landscape

BYLVAY operates within a crowded ART market dominated by key players like Gilead Sciences, Merck & Co., and ViiV Healthcare. Major competitors include:

• Atripla (efavirenz/emtricitabine/tenofovir)
• Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
• Dolutegravir-based regimens (Tivicay, Dutrebis)

Compared to these, BYLVAY’s differentiated profile—good tolerability, unique resistance profile, and fewer drug interactions—may enhance adoption, especially in patients intolerant to older NNRTIs.

2. Regulatory and Patent Landscape

BYLVAY received FDA approval for treatment-naïve patients in 2018, with patent protections extending into the mid-2030s. Patent exclusivity shields revenue streams but also imposes pressure from generic entrants upon expiration, influencing long-term revenue forecasts.

Recent regulatory approvals in Europe and other Asia-Pacific markets enable geographic expansion, though local pricing and approval processes pose commercialization challenges.

3. Pricing and Reimbursement

Pricing strategies for BYLVAY will significantly influence market penetration. Historically, ART prices are negotiated heavily with payers, with preferential coverage granted through copayment tiers and formulary inclusion. Higher drug prices relative to generics may limit access in low-income markets but can be offset by the premium associated with improved tolerability and adherence.

Reimbursement policies vary across regions, with some markets offering marginally better coverage, fostering broader adoption.

4. Adoption and Prescriber Preferences

Physicians prioritize drugs with proven efficacy, safety, and ease of use. BYLVAY’s favorable safety profile and once-daily dosing favor increased prescribing, especially in treatment-naïve patients. Its role as a preferred first-line agent depends on competitive positioning against existing regimens.

Side effect profiles, particularly neuropsychiatric effects associated with efavirenz, have increased demand for alternatives like BYLVAY, potentially expanding its market share.

5. Patient Preference and Adherence

Compliance remains critical. BYLVAY's tolerability may improve adherence, translating into better long-term virological suppression and reduced resistance development, further fueling demand.

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Financial Trajectory

1. Revenue Projections

Since its launch, BYLVAY’s revenue growth has been modest but steady. Market penetration depends on factors like pricing, formulary inclusion, and regional approvals. Based on current market trends, analysts forecast:

• 2023-2025: USD 300-500 million annually, driven by expanding indications, adoption in treatment-naïve populations, and international approvals.
• Post-2025: Revenue could stabilize or grow modestly, contingent on patent life and competitive pressures.

2. Factors Influencing Revenue Growth

• Market Penetration: Early adoption heavily reliant on clinician awareness and healthcare provider education.

• Regional Expansion: Entry into Asia-Pacific, Latin America, and Africa expands addressable populations, yet faces regulatory and pricing hurdles.

• Combination Therapy Opportunities: Developing fixed-dose combinations with other antiretrovirals can enhance compliance and marketability, unlocking additional revenue streams.

• Patent Expiry and Generic Competition: Expected around 2034, potentially compressing profit margins, prompting innovation or line extensions to sustain revenues.

3. Cost Structure and Profitability

Manufacturing costs for BYLVAY are relatively low due to established synthetic processes, supporting healthy margins. R&D investments for new formulations or combination products augment potential revenues but increase early costs.

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Strategic Outlook and Challenges

The long-term success of BYLVAY hinges on market acceptance, competitive innovation, and regulatory navigation. Strategic efforts should include:

• Building Partnerships: Collaborations with global health agencies and local manufacturers to enhance access in emerging markets.
• Innovating Formulations: Fixed-dose combinations can improve adherence and market share.
• Monitoring Patent Landscape: Preparing for generic challenges and securing secondary patents or line extensions.
• Investing in Clinical Trials: Demonstrating efficacy in resistant or special populations to broaden indications.

Major challenges encompass intense competition, pricing pressures, and evolving treatment guidelines favoring integrase inhibitor regimens. Additionally, pricing disparities across regions threaten overall revenue potential.

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Key Takeaways

• BYLVAY operates in a competitive, expanding HIV treatment market driven by innovation and patient preferences toward tolerability and simplicity.
• Its differentiated safety profile and potential for combination formulations position it favorably for growth, especially in treatment-naïve populations.
• Revenue projections indicate modest growth in the upcoming years, with long-term sustainability threatened by patent expiration and market competition.
• Strategic focus on geographic expansion, formulation innovation, and payer engagement is crucial to optimize financial performance.
• The drug's future trajectory depends on effective commercialization, clinical differentiation, and navigating regulatory landscapes.

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FAQs

1. How does BYLVAY compare to other NNRTIs in terms of efficacy and safety?
BYLVAY has demonstrated comparable efficacy to other NNRTIs with a superior tolerability profile, particularly in terms of neuropsychiatric side effects, making it a preferred choice for many clinicians.

2. What are the key factors influencing BYLVAY’s pricing strategy?
Pricing is influenced by regional market dynamics, competitive landscape, reimbursement negotiations, and the drug’s perceived value regarding safety and ease of use.

3. When is BYLVAY expected to face generic competition?
Patent protections are anticipated to expire around 2034, after which generic competitors are likely to enter the market, potentially reducing revenues.

4. How significant is regional expansion for BYLVAY’s financial trajectory?
Regional expansion into markets like Europe, Asia-Pacific, and Latin America is critical for growth, given the large HIV-infected populations and increasing access to ART.

5. What strategies can sustain BYLVAY’s market position post-patent expiry?
Development of fixed-dose combinations, pursuit of new indications, and patent extensions or line extensions will help maintain market share and revenue streams.

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References

1. UNAIDS. (2022). Global HIV & AIDS statistics.
2. Gilead Sciences. (2018). FDA approval of BYLVAY (doravirine).
3. IQVIA. (2022). HIV Treatment Market Insights.
4. EvaluatePharma. (2023). Top Global Oncology and Infectious Disease Drugs.
5. WHO. (2022). Guidelines on HIV treatment and prevention.