ODEVIXIBAT - Generic Drug Details

What are the generic drug sources for odevixibat and what is the scope of freedom to operate?

Odevixibat is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Odevixibat has one hundred and fifteen patent family members in forty-two countries.

Two suppliers are listed for this compound.

Summary for ODEVIXIBAT

International Patents:	115
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	4
Patent Applications:	174
What excipients (inactive ingredients) are in ODEVIXIBAT?	ODEVIXIBAT excipients list
DailyMed Link:	ODEVIXIBAT at DailyMed

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

Constraining patent/regulatory exclusivity:

10,975,046

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.

Recent Clinical Trials for ODEVIXIBAT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Albireo	Phase 3

See all ODEVIXIBAT clinical trials

Pharmacology for ODEVIXIBAT

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

Anatomical Therapeutic Chemical (ATC) Classes for ODEVIXIBAT

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ODEVIXIBAT

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;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes	10,975,046			Y
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,975,046			Y

Expired US Patents for ODEVIXIBAT

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

EU/EMA Drug Approvals for ODEVIXIBAT

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 ODEVIXIBAT

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3810084
European Patent Office	3777864	INHIBITEURS IBAT POUR LE TRAITEMENT DE MALADIES DU FOIE (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES)
Denmark	3023102

Supplementary Protection Certificates for ODEVIXIBAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3400944	22C1002	France		PRODUCT NAME: ODEVIXIBAT OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: EU/1/21/1566 20210719; FIRST REGISTRATION: - 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	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

ODEVIXIBAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Odevixibat (Bylvay)

Introduction

Odevixibat, marketed as Bylvay, is a groundbreaking drug developed by Albireo Pharma for the treatment of rare liver diseases, particularly Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). This article delves into the market dynamics and financial trajectory of odevixibat, highlighting its clinical efficacy, market performance, and financial outlook.

Clinical Efficacy and Approval

Odevixibat has demonstrated significant clinical efficacy in reducing pruritus and lowering serum bile acid levels in patients with PFIC and ALGS. The PEDFIC 1 study, published in The Lancet, showed that odevixibat significantly reduced pruritus and serum bile acid levels compared to placebo, leading to its approval in the USA and EU in 2021[4].

Market Launch and Adoption

Following its approval, Bylvay was launched in the U.S. and Europe in 2021. The initial response from healthcare providers, patients, and payors has been positive. As of Q3 2022, Bylvay had been prescribed to 245 patients, representing an 18% growth compared to Q1 2022. The unique prescriber base in the U.S. also increased from 57 to 73 during the same period[5].

Revenue Performance

Quarterly and Annual Revenue

Bylvay generated $7.5 million in net product revenue in Q3 2022, with $4.1 million from the U.S. and $3.4 million from international markets. For the year ended December 31, 2021, Bylvay net product revenue was $7 million, with $5.3 million from the U.S. and $1.7 million from international markets[2][3].

Growth Trends

The revenue has shown a steady growth trend. In Q2 2022, Bylvay net product revenue was $5.9 million, with a year-to-date total of $10.5 million. This growth is attributed to increased sales and the expansion of Bylvay into additional countries[5].

Reimbursement and Market Access

Bylvay has secured reimbursement in several key markets, including the U.S., Germany, the United Kingdom, Italy, and Belgium. In France, the pricing and reimbursement negotiation with the Economic Committee for Health Products (CEPS) was concluded, enabling reimbursement for patients in the near future[2][5].

Financial Highlights

Product Revenue

For the year ended December 31, 2021, Bylvay contributed $7 million to Albireo's product revenue, primarily driven by patient sales and initial inventory stocking at specialty pharmacies[3].

Royalty and License Revenue

In addition to product revenue, Albireo also generated royalty revenue. For Q3 2022, royalty revenue was $2.3 million, although this was slightly lower than the previous year. License revenue was significant in 2021, with $15 million received from a Japan licensing agreement[2][3].

Research and Development Expenses

Research and development expenses increased due to clinical program activities. For Q3 2022, R&D expenses were $23.3 million, up from $21.1 million in the same period of 2021. This increase is largely due to ongoing Phase 3 studies in ALGS and biliary atresia[2].

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses also saw an increase, driven by personnel and commercialization activities. For Q3 2022, these expenses were $20.6 million, up from $17.6 million in the same period of 2021[2].

Net Loss and Cash Position

Despite the revenue growth, Albireo reported a net loss of $37.8 million for Q3 2022, primarily due to increased R&D and SG&A expenses. However, the company had a robust cash position of $272.5 million as of September 30, 2022, which is expected to be sufficient to fund operations beyond the top-line data readout of the BOLD study in biliary atresia in 2024[2].

Future Outlook

Ongoing and Upcoming Studies

Albireo is continuing to enroll patients in several Phase 3 studies, including the ASSERT study for ALGS and the BOLD study for biliary atresia. Positive outcomes from these studies could further enhance Bylvay's market position and expand its indications[2][3].

Global Expansion

The company is planning to launch Bylvay in additional countries, which is expected to drive further revenue growth. The positive response from healthcare providers and payors in existing markets bodes well for future expansion[3].

Competitive Landscape

Bylvay's unique mechanism of action as a luminally restricted, potent, selective IBAT inhibitor positions it favorably in the market for rare liver diseases. It offers a non-surgical, pharmacological option to interrupt the enterohepatic circulation, addressing high unmet medical needs in PFIC and ALGS[4].

Key Takeaways

• Clinical Efficacy: Odevixibat has shown significant efficacy in reducing pruritus and serum bile acid levels in patients with PFIC and ALGS.
• Market Adoption: Bylvay has seen positive adoption with increasing prescriptions and a growing prescriber base.
• Revenue Growth: Steady revenue growth has been observed, with $7.5 million in Q3 2022 and $7 million for the year ended December 31, 2021.
• Reimbursement: Secured reimbursement in key markets, including the U.S., Germany, UK, Italy, and Belgium.
• Financial Position: Despite net losses, Albireo has a strong cash position to support ongoing and future clinical studies and market expansion.

FAQs

What is odevixibat (Bylvay) used for?

Odevixibat, marketed as Bylvay, is used for the treatment of pruritus in patients with Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

When was odevixibat approved?

Odevixibat was approved in the USA and EU in 2021 for the treatment of PFIC and ALGS.

What are the key clinical benefits of odevixibat?

Odevixibat reduces pruritus and lowers serum bile acid levels, potentially reducing the need for liver transplantation and delaying disease progression.

How has the market responded to Bylvay?

The market response has been positive, with increasing prescriptions, a growing prescriber base, and secured reimbursement in several key markets.

What is the financial outlook for Albireo Pharma regarding Bylvay?

Albireo expects continued revenue growth from Bylvay, supported by a strong cash position to fund ongoing and future clinical studies and market expansion.

Sources

1. Globenewswire: Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS.
2. Globenewswire: Albireo Reports Q3 2022 Financial Results and Business Update.
3. Biospace: Albireo Reports Q4 and Year-End 2021 Financial Results and Business Update.
4. The Lancet: Odevixibat treatment in progressive familial intrahepatic cholestasis.
5. Biospace: Albireo Reports Q2 2022 Financial Results and Business Update.