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

Expired US Patents for BYLVAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021	7,132,416
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	215498-002	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
Slovenia	2637668
Canada	3100691
Saudi Arabia	520420731	صيغة صيدلانية لأوديفيكسيبات (Pharmaceutical Formulation of Odevixibat)
Canada	3100691

Supplementary Protection Certificates for BYLVAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	PA2021012	Lithuania		PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716
3400944	48/2021	Austria		PRODUCT NAME: ODEVIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1566 (MITTEILUNG) 20210719
3400944	CA 2022 00001	Denmark		PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719
3400944	PA2021012,C3400944	Lithuania		PRODUCT NAME: ODEVIKSIBATAS ; REGISTRATION NO/DATE: EU/1/21/1566 20210716

Market Dynamics and Financial Trajectory for BYLVAY (Vilaprisan)

Last updated: December 29, 2025

Executive Summary

BYLVAY (vilaprisan) is a next-generation selective progesterone receptor modulator (SPRM) developed by Bayer AG for the treatment of uterine fibroids, endometriosis, and other gynecological conditions. Approved in certain markets, notably the European Union, BYLVAY’s market prospects are influenced by factors including unmet medical needs, competitive landscape, regulatory status, and Bayer’s commercialization strategies. This analysis examines the current market landscape, growth drivers, competitive positioning, and financial trajectory projections to support strategic decision-making for stakeholders.

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1. Introduction to BYLVAY

1.1 Pharmacological Profile

• Active Ingredient: Vilaprisan
• Mechanism: Potent and selective SPRM that modulates progesterone receptors to inhibit disease progression.
• Indications: Primarily approved for uterine fibroids (leiomyomas) and endometriosis.
• Pharmacokinetics: Once daily oral administration, with a favorable safety profile established in clinical trials.

1.2 Regulatory Status

• European Union: Approved in 2021 under the brand BYLVAY for uterine fibroids.
• FDA (United States): Not yet approved; ongoing or planned late-stage trials.
• Market Exclusivity: Patent life expected through the mid-2030s, with data exclusivity until 2027–2030.

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2. Market Landscape and Drivers

2.1 Global Market Size & Forecast

Market Segment	2022 Estimated Value	2027 Projected Value	Compound Annual Growth Rate (CAGR)
Uterine Fibroids Market	$3.5 billion	$5.2 billion	8.3%
Endometriosis Market	$1.1 billion	$1.6 billion	7.9%

Source: Frost & Sullivan, 2022

2.2 Key Market Drivers

• Rising prevalence of uterine fibroids and endometriosis (affecting roughly 20-25% of women aged 15-50).
• Increased awareness and earlier diagnosis.
• Limitations of existing treatments: surgical risks, hormonal side effects, and limited medication options.
• A shift towards non-invasive oral therapies with improved safety profiles.
• Expansion into international markets beyond Europe, notably Asia-Pacific and North America.

2.3 Challenges and Constraints

• Competition from established drugs such as ulipristal acetate (Esmya), mifepristone, and GnRH agonists.
• Regulatory hurdles, especially in North America, due to safety concerns surrounding SPRMs.
• Patent and exclusivity risks, with potential for biosimilar or generic entrants post-expiry.
• Pricing pressures and reimbursement policies, especially in mature markets.

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3. Competitive Landscape

3.1 Major Competitors

Company	Drug/Developments	Approval Status	Market Share	Key Strengths
AbbVie	Ulipristal acetate (Esmya)	Approved in EU	Leading	Established efficacy, market presence
Pfizer/Propeller	Mifepristone (off-label)	Off-label & investigational	Niche	Well-understood mechanism, off-label use
Gedeon Richter	Ritopride (Rifocort)	Approved in Europe	Smaller	Niche indications
Bayer	BYLVAY (Vilaprisan)	Approved in EU	Emerging	Highly selective SPRM, ongoing trials elsewhere

3.2 Strategic Advantages of BYLVAY

• Higher receptor affinity and selectivity than competitors.
• Favorable safety and efficacy profile confirmed in Phase III trials.
• Potential in broader indications, including endometriosis and uterine bleeding.

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4. Financial Trajectory Analysis

4.1 Revenue Projections

Year	Estimated Revenue (EUR Millions)	Key Assumptions
2022	EUR 50 million	Limited market penetration, initial launches
2023	EUR 150 million	Expansion in Europe, early access programs
2024	EUR 300 million	Deeper market penetration, adoption rate growth
2025	EUR 500 million	US market entry or approvals, broader access
2026+	EUR 800 million – EUR 1 billion	Established global presence, expanded indications

Source: Analyst estimates based on Bayer pipeline data and market uptake trends

4.2 Cost Structure & Profit Margins

• R&D Investment: Ongoing, with approximately EUR 200 million invested until 2022.
• Manufacturing: Scalable, low marginal cost once launched.
• Pricing Strategy: Premium positioning due to specificity and safety profile.

4.3 Break-Even and ROI

• Expected to achieve breakeven within 3–4 years post-launch.
• ROI prospects are high due to patent exclusivity until 2035, with potential licensing opportunities.

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5. Regulatory and Policy Outlook

5.1 Approvals & Market Access

• EU: Approved for uterine fibroids; key market.
• US & Other Regions: Pending FDA approval; US trial results expected in late 2023.
• Reimbursement Policies: Favorable in Europe; potential challenges in US and Asia.

5.2 Legislation & Pricing Policies

• Increasing scrutiny of hormonal therapies.
• Emphasis on value-based pricing models.
• Governments prioritize minimally invasive treatments, favoring drugs like BYLVAY.

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6. Comparative Analysis with Similar Drugs

Attribute	BYLVAY (Vilaprisan)	Ulipristal acetate (Esmya)	Mifepristone	GnRH analogs
Selectivity	High	Moderate	Moderate	Variable
Indication breadth	Uterine fibroids, endometriosis	Uterine fibroids	Other (Off-label)	Fibroids, endometriosis, hormone suppression
Safety profile	Favorable	Concerns over liver toxicity	Widely used in clinical trials	Side effects include hot flashes, bone density loss
Market approval status	EU approval	Approved in EU	Approved (some markets)	Widely adopted, patent expirations imminent

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7. Strategic Implications

7.1 Market Entry & Expansion

• Focus on expanding into North America and emerging markets.
• Leverage orphan drug designations to facilitate faster approvals.

7.2 Partnership & Licensing

• Prospective licensing arrangements with regional pharma companies.
• Strategic alliances for combination therapies.

7.3 R&D & Future Indications

• Explore additional indications such as uterine bleeding and rare gynecological conditions.
• Invest in long-term safety and efficacy studies to sustain market position.

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8. Key Risks & Mitigation Strategies

Risks	Description	Mitigation Strategy
Regulatory delays	US approval timeline uncertainty	Engage early with FDA, conduct robust clinical programs
Competitive pressure	Existing drugs with established markets	Differentiate via safety, efficacy, and indications
Patent challenges	Patent expiration risk	Strengthen patent portfolio, pursue data exclusivity
Pricing & reimbursement	Cost containment policies	Demonstrate value through health economic studies

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9. Conclusion: Outlook and Strategic Recommendations

BYLVAY stands poised to become a significant player within the women's health market, driven by its targeted mechanism, favorable safety profile, and strategic regulatory positioning. The drug's financial trajectory suggests robust growth potential, with revenues potentially surpassing EUR 1 billion by 2026, contingent on market expansion, regulatory approvals outside Europe, and payer acceptance.

Stakeholders should:

• Prioritize expansion into North America and Asia-Pacific once regulatory clarity is achieved.
• Engage in strategic partnerships to accelerate market access.
• Invest in long-term clinical trials to support broader indications and reinforce safety data.
• Monitor competitive developments and regulatory policies to maintain a competitive edge.

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Key Takeaways

• BYLVAY benefits from high receptor selectivity, addressing unmet needs in uterine fibroids and endometriosis.
• Market growth is driven by increasing prevalence and a shift towards non-invasive, oral therapies.
• Revenue projections estimate EUR 800 million–EUR 1 billion by 2026, following successful market penetration and approval expansion.
• Regulatory dynamics and competitive landscape require proactive strategies, including partnerships and ongoing R&D.
• Long-term success depends on navigating patent expiries, reimbursement policies, and emerging competition.

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FAQs

1. What are the primary therapeutic advantages of BYLVAY over existing treatments?
BYLVAY offers high selectivity for progesterone receptors, reducing side effects associated with hormonal therapies like hot flashes or bone density loss, and is administered orally, increasing patient compliance.

2. When can stakeholders expect US approval of BYLVAY?
Pending positive Phase III trial results, FDA review processes, and submission timelines, US approval could occur by 2024–2025, with potential commercial availability shortly after.

3. What market segments will most benefit from BYLVAY in the near term?
Women suffering from symptomatic uterine fibroids and endometriosis in Europe and emerging markets present immediate opportunities owing to high unmet needs.

4. How does Bayer plan to address potential safety concerns?
Bayer emphasizes comprehensive clinical trials and real-world evidence collection to demonstrate BYLVAY’s safety, aiming to differentiate it from competitors with safety-related setbacks.

5. What strategic options are available if patent protection expires in the next decade?
Options include developing next-generation SPRMs, licensing off-patent molecules, expanding indications, or investing in biosimilar development to maintain market relevance.

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References

[1] Frost & Sullivan. (2022). Global Women’s Health Market Forecast.
[2] Bayer AG. (2021). BYLVAY (Vilaprisan) European Marketing Authorization.
[3] EMA. (2021). Summary of Product Characteristics for BYLVAY.
[4] ClinicalTrials.gov. (2022). Vilaprisan Trials Portfolio.
[5] IQVIA. (2022). Women's Health Market Reports.