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 sixteen patents protecting this drug.

This drug has one hundred and thirty-four 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:	134
US Patents:	16
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-eight 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	215498-002	Jul 20, 2021		RX	Yes	No	10,093,697
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes	10,487,111
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,093,697
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	12,187,812

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	215498-003	Jul 20, 2021	7,132,416
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	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 Africa

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
Australia	2011326871
Brazil	112013010157
Canada	2815749
China	103260625
China	105288580

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	LUC00242	Luxembourg		PRODUCT NAME: ODEVIXIBAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BYLVAY); AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719
3400944	301157	Netherlands		PRODUCT NAME: ODEVIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION 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
3400944	2021C/554	Belgium		PRODUCT NAME: ODEVIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719

BYLVAY (odevixibat) Market Dynamics and Financial Trajectory: Exclusivity, competition risk, and revenue path

Last updated: July 24, 2026

Executive summary:
BYLVAY (odevixibat; Mirum Pharmaceuticals) is a chronic, growth-constrained niche therapy in pediatric and adult progressive familial intrahepatic cholestasis (PFIC). Near-term market dynamics hinge on (1) adoption breadth across PFIC subtypes, (2) formulary and payer coverage for a high-cost oral therapy, (3) competitive pressure from other cholestasis-focused pipelines, and (4) durability of pediatric label expansion. The financial trajectory is primarily driven by volume scaling within PFIC, dose continuity, and expanding prescriber awareness, with downside risk from slower-than-expected conversion of treated patients and payer utilization management that can delay uptake.

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What is BYLVAY (odevixibat) and what market does it address?

Short answer: BYLVAY is positioned for PFIC, where intestinal bile acid transport modulation aims to reduce cholestasis-related bile flow abnormalities. The commercial market is concentrated in pediatric hepatology and referral centers and is limited by the size of eligible PFIC populations.

PFIC commercial segmentation by patient type

• PFIC is rare and split across genetic subtypes, driving uneven addressable populations by label language and guideline adoption.
• Real-world commercial addressability is determined by:
  • Referral center density and pediatric hepatology footprint
  • Diagnostic throughput and time-to-genotyping
  • Willingness to start earlier in childhood
  • Long-term adherence in chronic therapy

BYLVAY therapy class and buyer profile

• Buyer is typically a pharmacy benefit (commercial) or specialty drug program (government), with clinical review by hepatology specialists.
• Decision-making is affected by:
  • Severity of cholestasis and prior therapy history
  • Need for durable itch and liver marker improvements
  • Required prior authorizations and step edits

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How does BYLVAY pricing and payer coverage shape uptake and revenue?

Short answer: Revenue trajectory depends more on payer approvals and utilization management than on marketing alone, because PFIC is rare and patient-level access determines total volume.

What payer levers most influence utilization

• Prior authorization with clinical criteria tied to:
  • PFIC diagnosis confirmation
  • Baseline labs and symptom documentation
  • Failure or intolerance of other regimens
• Specialty pharmacy dispensing and reauthorization cadence for continued coverage
• Pharmacy benefit design that can steer sites of care (hospital vs retail specialty)

Formulary access dynamics

In rare disease, payer skepticism concentrates around:

• Budget impact at the patient level (dose is weight-based in pediatrics)
• Long-term outcomes evidence and durability expectations
• Comparative value versus existing off-label or standard-of-care approaches

These dynamics usually produce a “coverage ramp” pattern where revenue growth lags early prescribing until payer throughput improves.

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What exclusivity protects BYLVAY and when does it lose exclusivity?

Short answer: BYLVAY’s exclusivity profile determines long-range revenue defensibility, while near-term competition is driven more by practical market access than patent strategy until late-stage milestones approach.

Patent term and exclusivity framework (what matters for financial modeling)

For small-molecule oral rare disease drugs, revenue durability typically tracks:

• Composition-of-matter patent term (primary)
• Patents covering crystalline forms, particle size, or specific manufacturing controls (secondary)
• Method-of-treatment or patient selection (often weaker but can delay carve-outs)
• Orphan drug exclusivity (if applicable) and any pediatric exclusivity extension
• Any Hatch-Waxman listing that constrains generic approvals

How exclusivity affects generic entry risk

• Even if market exclusivity exists, payer uncertainty can reduce revenue if clinicians expect later competition and if budgets tighten.
• If exclusivity expires, generic risk is tied to:
  • Bioequivalence feasibility and formulation patent barriers
  • Paragraph IV challenges (for ANDA applicants) if listed patents enable certifications

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What is the Orange Book status of BYLVAY and what patent list volumes matter for generics?

Short answer: Generic entry timing is determined by the Orange Book patent list, not by the label alone. The number and quality of listed patents affects how many potential barriers an ANDA filer must address.

Orange Book-driven risk map for ANDAs

When assessing financial exposure, track:

• Which patents are “listed” and whether they are:
  • composition-of-matter
  • formulation/manufacturing
  • method-of-use
• Whether patents appear to be continuously listed across submission updates
• Litigation history connected to those listed patents

Generic launch scenario logic

For a therapy like BYLVAY:

• The base-case revenue curve is “slow ramp under coverage ramp.”
• The downside-case is “coverage delays plus faster-than-expected pipeline substitutions.”
• The generic-case is “generic arrival only after patent or exclusivity resolution and ANDA readiness.”

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Which companies are challenging BYLVAY and what Paragraph IV litigation affects entry?

Short answer: Paragraph IV challenges and associated court outcomes determine when an ANDA can launch, but BYLVAY’s market size and niche usage typically mean that even a successful generic challenge may take time to translate into volume due to specialty channel inertia.

Litigation pathways that shift commercial timing

• Filing of ANDA and certification type (Paragraph IV vs others)
• Court injunctions and whether the 30-month stay applies
• Settlement agreements that:
  • delay launch date
  • constrain labeling or distribution
  • include “no-AG” terms on certain strengths or presentations

Settlement-driven revenue impact

Settlement outcomes often create:

• A defined “last protected launch” window
• A predictable competitive timeline for internal forecasting
• A change in payer messaging as pharmacies anticipate generic substitution

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Is BYLVAY at risk from biosimilars, and how does biosimilar competition differ?

Short answer: BYLVAY is a small molecule, so biosimilar risk is not the relevant pathway. Competition risk is primarily generic and other small-molecule or bile-acid transport modulator entrants.

Implication for financial trajectory

• Switching dynamics in small molecules usually occur faster than for biologics if generic entry is permitted.
• Payer and specialty pharmacy substitution can happen quickly post-launch, depending on pricing and contracting.

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How many patents cover BYLVAY formulations and manufacturing, and do they block generics?

Short answer: Formulation and manufacturing patents matter because they can force generic applicants into more complex development, increasing launch delays even when composition patents are nearing expiration.

Formulation/method barriers to model

Focus on patents that cover:

• Solid-state form (polymorph/crystal form)
• Particle size and morphology
• Stability/processing parameters (drying, milling, compression controls)
• Specific excipient systems or coating approaches

For ORAL small molecules, such barriers often shift generic timelines more than they stop entry entirely, but they can matter financially for peak sales capture.

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How does BYLVAY compare with alternative cholestasis treatments commercially?

Short answer: In PFIC, alternative approaches include bile acid therapies, symptom control regimens, and other specialized interventions. BYLVAY’s ability to win access depends on payer-perceived differentiation and clinician adoption.

Comparison axes that affect market share

• Symptom burden (itch and quality of life)
• Biochemical marker improvement
• Downstream clinical endpoints that payers value (hospitalizations, escalation to procedural interventions)
• Evidence strength in pediatric cohorts

Competitive substitution patterns

• If competitors show similar clinical effects with better payer acceptance, BYLVAY’s volume ramp can flatten.
• If BYLVAY becomes the default hepatologist-prescribed option, revenue growth can outpace patient population growth via improved referral usage.

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What is BYLVAY’s FDA regulatory path and what milestones impact revenues?

Short answer: Revenue trajectory correlates with approval timing, label expansions, and post-marketing utilization patterns rather than with technical manufacturing milestones.

Milestones that typically drive commercial step-changes

• Initial approval and launch readiness
• Pediatric expansion approvals and related dosing approvals
• Any new indications that broaden addressable PFIC subgroups
• Safety communications that affect persistence and prescribing behavior

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What generic entry risks exist for BYLVAY and when do they peak?

Short answer: Generic entry risk peaks when primary patent and any exclusivity protection expires and when listed Orange Book patents are no longer enforceable or enjoined.

Peak risk model for revenue forecasts

Use a three-layer risk model:

1. Legal timeline risk: patent expiration and litigation/settlement outcomes
2. Regulatory timeline risk: ANDA readiness and approval status
3. Commercial timeline risk: payer contracting and formulary replacement

In rare disease, even after approval, volume can lag due to specialty contracting and clinician inertia.

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What are the most likely revenue drivers and revenue leak points for BYLVAY?

Short answer: The upside case depends on widening PFIC coverage and sustained adherence; the downside case comes from payer friction and slow conversion of diagnosed patients.

Revenue drivers

• Increased treated prevalence in PFIC through:
  • guideline awareness
  • referral center adoption
  • improved diagnostic confirmation rates
• Persistence (chronic use), dose optimization, and fewer discontinuations
• Specialty pharmacy scaling and smoother prior authorization workflows

Revenue leak points

• Delay in payer approvals and step therapy requirements
• Higher discontinuation rates than modeled (tolerability or perceived benefit)
• Lower-than-forecast treated population due to diagnostic bottlenecks
• Faster substitution from competing cholestasis pipeline entrants after label confidence grows

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Key financial trajectory framework for BYLVAY: what to model each year

Short answer: Build annual projections using patient ramp, pricing net of rebates, persistence, and competitive entry probability.

Forecast variables that typically explain 90% of variance

• Treated patient count by year (start rate and persistence)
• Net price after rebates and discounts (payer-specific)
• Dose intensity by weight and age (pediatric dosing variability)
• Switch/discontinuation rate
• Market expansion via label changes and guideline adoption

Market dynamic interpretation

A rare disease profile usually shows:

• Early prescribing adoption that outpaces paid claims until payer processes stabilize
• Mid-stage growth driven by clinician habit formation
• Late-stage deceleration if competitive options or cost pressures increase

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Key Takeaways

• BYLVAY’s financial trajectory is dominated by access: rare disease volume is small enough that payer approvals, specialty channel execution, and diagnostic-to-treatment conversion determine outcomes.
• Competitive risk is primarily generic or alternative small-molecule bile acid transport approaches; biosimilar risk does not apply.
• Patent and exclusivity status, together with Orange Book listings and any Paragraph IV litigation, determine the legal clock for generic substitution and the timing of revenue compression.
• Revenue forecasting should focus on treated patient ramp, persistence, and net pricing rather than only on label breadth.

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FAQs

1) What drives early BYLVAY adoption in PFIC?
Payer approvals, referral center prescribing, and evidence-based clinician confidence in pediatric use are primary drivers.

2) What utilization management steps slow BYLVAY volume ramp?
Prior authorizations with clinical documentation requirements and step edits against alternative regimens typically delay paid claims.

3) How should generic risk be modeled for BYLVAY?
Model legal readiness (Orange Book and litigation), regulatory readiness (ANDA approval), then commercial readiness (payer formulary and contracting).

4) Does BYLVAY face biosimilar competition?
No. BYLVAY is a small molecule; the primary substitution threat is generic small-molecule entry, not biosimilars.

5) What information typically signals a change in BYLVAY’s revenue trajectory?
Payer formulary expansions or denials, safety communications affecting persistence, and label or guideline shifts that change treated prevalence.

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References

No specific sources were cited.

DrugChatter Q&A for BYLVAY

Is bylvay licenced in brazil?