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BYLVAY Drug Patent Profile

Which patents cover Bylvay, and what generic alternatives are available?

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

This drug has one hundred and fifteen patent family members in forty-two 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 will be eligible for patent challenges on July 20, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	115
US Patents:	12
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 thirty-three 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, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes			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
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	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/004691 Bylvay 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

Ecuador

European Patent Office

Israel

Japan

Jordan

Mexico

Nicaragua

Peru

Philippines

Singapore

South Korea

Taiwan

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
Chile	2020003295	Modificaciones de cristales de odexibat
Japan	3616635
Mexico	2020013774
South Africa	200401798	Benzothiazepine and benzothiadiazepine derivatives with ileal bile acid transport (IBAT) inhibitory activity for the treatment of hyperlipidaemia.

Supplementary Protection Certificates for BYLVAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	2190043-6	Sweden		PRODUCT NAME: ODEVIXIBAT; REG. NO/DATE: EU/1/21/1556 20210719

BYLVAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bylvay (odevixibat)

Introduction

Bylvay, developed by Albireo Pharma, is a groundbreaking drug approved for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) and more recently for Alagille syndrome. This article delves into the market dynamics and financial trajectory of Bylvay, highlighting its sales performance, clinical advancements, and financial health of the company.

Approval and Indications

Bylvay, an ileal bile acid transport inhibitor (IBATi), was approved by the U.S. FDA in 2021 for the treatment of pruritus in patients with PFIC aged 3 months and older, and in Europe for patients aged 6 months and older[1][4].

Expansion of Indications

In June 2023, Bylvay received FDA approval for the treatment of cholestatic pruritus in patients with Alagille syndrome aged 12 months and older. This marks the second rare cholestatic liver disease indication for Bylvay in the U.S.[4].

Sales Performance

Initial Sales Guidance and Actuals

Albireo initially guided Bylvay net sales for 2021 to be between $3-4 million but later revised this to $6-7 million, reflecting a faster-than-anticipated uptake of the drug[1].

Quarterly Sales Updates

• In Q1 2022, Bylvay generated $4.7 million in net product revenue globally[3].
• In Q2 2022, Bylvay net product revenue was $5.9 million, with $3.5 million from the U.S. and $2.4 million from international markets[5].
• In Q3 2022, Bylvay net product revenue increased to $7.5 million, with $4.1 million from the U.S. and $3.4 million from international markets[2].

Annual Sales Projections

For the full year 2022, Albireo projected Bylvay sales to be around $24 million, indicating a significant growth trajectory from the initial year of launch[2][5].

Clinical Advancements

Phase 3 Studies

Albireo is conducting two pivotal Phase 3 studies:

• ASSERT Study: This study is evaluating Bylvay in patients with Alagille syndrome and is on track for topline data by the end of the year. The study has demonstrated efficacy in improving pruritus, sleep disturbances, and reducing bile acids with a low rate of drug-related diarrhea[1][4].
• BOLD Study: This study is focused on biliary atresia, the most common pediatric cholestatic liver disease with no approved drug treatment. The BOLD study has passed the 50% enrollment milestone and is expected to provide topline data in 2024[1].

Financial Health of Albireo Pharma

Cash Position

As of December 31, 2021, Albireo had unaudited cash and cash equivalents of at least $248 million. By September 30, 2022, this figure increased to $272.5 million, providing the company with sufficient capital to fund ongoing operations and development programs through at least 2024[1][2].

Revenue and Expenses

• Product Revenue: Bylvay has been the primary driver of product revenue, with significant increases quarter-over-quarter.
• Royalty Revenue: Albireo also generates royalty revenue, although this has seen minor fluctuations.
• Operating Expenses: The company has seen increases in selling, general, and administrative expenses due to personnel and commercialization activities related to Bylvay[2][5].

Net Loss

Despite the growth in revenue, Albireo has reported net losses. For Q3 2022, the net loss was $37.8 million, or $(1.92) per share. This is attributed to the ongoing investment in research and development, as well as commercialization efforts[2].

Market Dynamics

Reimbursement and Access

Bylvay has secured reimbursement approvals in several European markets, including France, which has enabled broader patient access. This has been a crucial factor in the drug's sales growth[2].

Competitive Landscape

Bylvay is the first approved drug for PFIC and Alagille syndrome, giving it a unique position in the market. Its orphan drug designations in both the U.S. and Europe further strengthen its market exclusivity[4].

Patient Enrollment and Treatment Benefits

The drug has shown significant benefits in clinical trials, including improvement in pruritus, sleep disturbances, and reduction in bile acids. These positive outcomes have contributed to its rapid adoption and enrollment in ongoing studies[1][4].

Key Takeaways

• Rapid Sales Growth: Bylvay has exceeded initial sales expectations, with a strong growth trajectory.
• Clinical Advancements: Ongoing Phase 3 studies in Alagille syndrome and biliary atresia are pivotal for expanding indications.
• Strong Financial Position: Albireo has a robust cash position to support continued development and commercialization.
• Market Exclusivity: Bylvay’s orphan drug designations and first-to-market status provide a competitive edge.
• Positive Clinical Outcomes: The drug has demonstrated significant treatment benefits, enhancing its adoption.

FAQs

What is Bylvay used for?

Bylvay is used for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome.

What are the current sales projections for Bylvay?

For 2022, Albireo projects Bylvay sales to be around $24 million.

What are the ongoing clinical studies for Bylvay?

Albireo is conducting Phase 3 studies for Bylvay in Alagille syndrome (ASSERT study) and biliary atresia (BOLD study).

How has Bylvay performed in clinical trials?

Bylvay has shown efficacy in improving pruritus, sleep disturbances, and reducing bile acids with a low rate of drug-related diarrhea in patients with Alagille syndrome.

What is Albireo Pharma’s current cash position?

As of September 30, 2022, Albireo had cash, cash equivalents, and restricted cash of $272.5 million.

Sources

1. Globenewswire: Albireo Increases 2021 Bylvay™ (odevixibat) Sales Guidance
2. Globenewswire: Albireo Reports Q3 2022 Financial Results and Business Update
3. Biospace: Albireo Reports Q1 2022 Financial Results and Business Update
4. Ipsen: U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome
5. Globenewswire: Albireo Reports Q2 2022 Financial Results and Business Update