Ozanimod hydrochloride - Generic Drug Details

What are the generic sources for ozanimod hydrochloride and what is the scope of freedom to operate?

Ozanimod hydrochloride is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ozanimod hydrochloride has one hundred and sixty-four patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for ozanimod hydrochloride

International Patents:	164
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	30
Patent Applications:	14
What excipients (inactive ingredients) are in ozanimod hydrochloride?	ozanimod hydrochloride excipients list
DailyMed Link:	ozanimod hydrochloride at DailyMed

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

Dosage:

CAPSULE;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 ozanimod hydrochloride

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

Sponsor	Phase
Geert D'Haens	Phase 4
I.R.C.C.S. Fondazione Santa Lucia	Phase 4
Bristol-Myers Squibb	Phase 3

See all ozanimod hydrochloride clinical trials

Pharmacology for ozanimod hydrochloride

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for ozanimod hydrochloride

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AE	Sphingosine-1-phosphate (S1P) receptor modulators
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ozanimod hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No

International Patents for ozanimod hydrochloride

Country	Patent Number	Title	Estimated Expiration
Lithuania	2498610
Canada	2986521	MODULATEURS SELECTIFS DU RECEPTEUR DE SPHINGOSINE-1-PHOSPHATE ET PROCEDES DE SYNTHESE CHIRALE (SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS)
Hong Kong	1175948	選擇性的 -磷酸鞘氨醇受體調節劑及手性合成方法 (SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS 1-)
New Zealand	589617	3-(Inden-4-yl)-5-(phenyl)-1,2,4-oxadiazole and 3-(tetralin-5-yl)-5-(phenyl)-1,2,4-oxadiazole derivatives

Supplementary Protection Certificates for ozanimod hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498610	20C1059	France		PRODUCT NAME: OZANIMOD OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER CHLORHYDRATE D'OZANIMOD; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2291080	2020C/539	Belgium		PRODUCT NAME: OZANIMOD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE D'OZANIMOD; AUTHORISATION NUMBER AND DATE: EU/1/20/1442 20200525
2498610	LUC00184	Luxembourg		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/20/1442 20200525
2291080	C02291080/01	Switzerland		PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020

Ozanimod hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ozanimod Hydrochloride

Introduction

Ozanimod hydrochloride, marketed as Zeposia, is a significant player in the treatment of relapsing forms of multiple sclerosis (MS) and other autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current market position, growth prospects, and economic implications.

Market Size and Growth

The global Ozanimod market is poised for substantial growth. As of 2024, the market size is estimated to be in the millions, with a compound annual growth rate (CAGR) of 6% projected from 2024 to 2031[1].

Regional Market Performance

North America

North America dominates the Ozanimod market, accounting for around 40% of the global revenue in 2024. This region is expected to grow at a CAGR of 4.2% from 2024 to 2031, driven by increasing incidences of autoimmune diseases, favorable reimbursement policies, and a strong healthcare infrastructure[1].

Europe

Europe is the fastest-growing region in the Ozanimod market, with a CAGR of 4.5% from 2024 to 2031. The growth is fueled by rising incidences of autoimmune diseases, a favorable regulatory environment, and growing investments in research and development[1].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue and is expected to grow at a CAGR of 8% from 2024 to 2031, making it a promising market for Ozanimod[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the market, with CAGRs of 5.4% and 5.7%, respectively, from 2024 to 2031[1].

Driving Factors

Increasing Incidence of Autoimmune Diseases

The rising incidence of autoimmune diseases such as multiple sclerosis and inflammatory bowel disease is a key driver of the Ozanimod market. As these diseases become more prevalent, the demand for effective treatments like Ozanimod increases[1].

Favorable Regulatory Environment

A favorable regulatory environment in regions like Europe and North America supports the growth of the Ozanimod market. Regulatory approvals and positive clinical trial outcomes have bolstered confidence among healthcare providers and patients[1][5].

Research and Development

Ongoing research and development efforts are crucial for the market's growth. Clinical trials, such as the RADIANCE and SUNBEAM trials, have demonstrated the efficacy and safety of Ozanimod, further solidifying its position in the market[2][5].

Economic Evaluation

Cost-Effectiveness

Ozanimod is more effective but also more costly than some other disease-modifying therapies (DMTs). For instance, it has an incremental cost-effectiveness ratio (ICER) of $68,833 per quality-adjusted life-year (QALY) gained compared to Avonex, and $2.2 million compared to teriflunomide[3].

Pharmacoeconomic Analysis

Pharmacoeconomic analyses, such as those conducted by CADTH, highlight that while Ozanimod is more effective than some DMTs, it is often dominated by other treatments like alemtuzumab in terms of cost-effectiveness. However, its unique efficacy profile and patient preference for oral administration contribute to its market value[3].

Clinical Efficacy and Safety

Clinical Trials

Clinical trials have shown that Ozanimod demonstrates sustained efficacy in treating relapsing-remitting multiple sclerosis. The RADIANCE Part A trial, for example, showed that Ozanimod reduced the annualized relapse rate and the number of new or enlarging T2 lesions over a two-year period[2].

Safety Profile

Ozanimod has a favorable safety profile, with no unexpected safety signals emerging in clinical trials. The incidence of serious treatment-emergent adverse events is relatively low, making it a tolerable option for patients[2].

Market Segments

Research and Medical

The Ozanimod market is driven by both research and medical segments. Research efforts continue to bolster the market's growth trajectory, while the medical segment, driven by increasing diagnoses and treatment options, is a significant force behind the market's expansion[1].

Competitive Landscape

Ozanimod competes with other DMTs in the MS treatment market. While it is more effective than some competitors, it faces stiff competition from drugs like alemtuzumab, fingolimod, and cladribine, which are often more cost-effective[3].

Regulatory Approvals

Ozanimod received FDA approval for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome and relapsing-remitting MS, based on the results of the SUNBEAM and RADIANCE trials[5].

Financial Implications

The financial trajectory of Ozanimod is influenced by its market size, growth rate, and cost-effectiveness. As the market expands, pharmaceutical companies are likely to invest more in marketing, research, and development to maintain and increase their market share.

Key Takeaways

• Market Growth: The global Ozanimod market is expected to grow at a CAGR of 6% from 2024 to 2031.
• Regional Dominance: North America and Europe are key regions driving the market growth.
• Driving Factors: Increasing incidence of autoimmune diseases, favorable regulatory environment, and ongoing research and development.
• Economic Evaluation: Ozanimod is more effective but more costly than some DMTs, with significant ICER values.
• Clinical Efficacy and Safety: Demonstrated sustained efficacy and a favorable safety profile in clinical trials.
• Market Segments: Driven by both research and medical segments.

FAQs

What is Ozanimod used for?

Ozanimod is used for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome and relapsing-remitting MS[5].

What is the projected CAGR for the Ozanimod market from 2024 to 2031?

The Ozanimod market is projected to grow at a CAGR of 6% from 2024 to 2031[1].

Which regions dominate the Ozanimod market?

North America and Europe are the dominant regions in the Ozanimod market, with North America accounting for around 40% of the global revenue[1].

How does Ozanimod compare to other DMTs in terms of cost-effectiveness?

Ozanimod is more effective but more costly than some DMTs, with an ICER of $68,833 per QALY gained compared to Avonex and $2.2 million compared to teriflunomide[3].

What are the key drivers of the Ozanimod market?

The key drivers include increasing incidence of autoimmune diseases, a favorable regulatory environment, and ongoing research and development efforts[1].

What is the safety profile of Ozanimod?

Ozanimod has a favorable safety profile with no unexpected safety signals emerging in clinical trials, and a low incidence of serious treatment-emergent adverse events[2].

Sources

1. Cognitive Market Research: Ozanimod Market Report.
2. NCBI: Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized, double-blind, placebo-controlled phase 2 study.
3. CADTH: Pharmacoeconomic Review Report for Ozanimod.
4. FDA: PRODUCT QUALITY REVIEW(S) for Ozanimod.
5. Cleveland Clinic: Ozanimod and Multiple Sclerosis.