ZEPOSIA Drug Patent Profile

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

Zeposia is a drug marketed by Bristol and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and seventy-seven patent family members in thirty-four countries.

The generic ingredient in ZEPOSIA is ozanimod hydrochloride. One supplier is listed for this compound. Additional details are available on the ozanimod hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Zeposia

Zeposia was eligible for patent challenges on March 25, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 24, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZEPOSIA

International Patents:	177
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	3
Patent Applications:	61
Drug Prices:	Drug price information for ZEPOSIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEPOSIA
What excipients (inactive ingredients) are in ZEPOSIA?	ZEPOSIA excipients list
DailyMed Link:	ZEPOSIA at DailyMed

See drug prices for ZEPOSIA

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

NDA:

209899

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 ZEPOSIA

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

Sponsor	Phase
University of Colorado, Denver	PHASE4
Geert D'Haens	Phase 4
Bristol-Myers Squibb	Phase 4

See all ZEPOSIA clinical trials

Pharmacology for ZEPOSIA

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

US Patents and Regulatory Information for ZEPOSIA

ZEPOSIA is protected by six US patents and two 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
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes			Y	Y
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	209899-001	Mar 25, 2020		RX	Yes	No			Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes			Y	Y

International Patents for ZEPOSIA

When does loss-of-exclusivity occur for ZEPOSIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

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 ZEPOSIA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20250558
Lithuania	2498610
Eurasian Patent Organization	201690391
European Patent Office	2498610
Eurasian Patent Organization	021672	МОДУЛЯТОРЫ РЕЦЕПТОРОВ СФИНГОЗИН-1-ФОСФАТА И ИХ ПРИМЕНЕНИЕ (MODULATORS OF SPHINGOSINE-1-PHOSPHATE RECEPTORS AND USE THEREOF)
Israel	267956
World Intellectual Property Organization (WIPO)	2011060392

Supplementary Protection Certificates for ZEPOSIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498610	CR 2020 00053	Denmark		PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525
2498610	C02498610/01	Switzerland		PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2291080	2020/042	Ireland		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2291080	785	Finland
2498610	PA2020533,C2498610	Lithuania		PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2291080	2090039-5	Sweden		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525
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

Market Dynamics and Financial Trajectory for ZEPOSIA

Last updated: July 27, 2025

Introduction

ZEPOSIA (ozanimod) is an oral disease-modifying therapy (DMT) developed by Celgene, now a Bristol-Myers Squibb (BMS) asset, approved for the treatment of relapsing forms of multiple sclerosis (RMS). Since its FDA approval in March 2020, ZEPOSIA’s commercial trajectory has been influenced by evolving market dynamics in multiple sclerosis (MS) therapeutics, regulatory developments, competitive positioning, and broader healthcare trends. This article analyzes the factors shaping ZEPOSIA’s market landscape and provides insights into its financial prospects.

Market Landscape for Multiple Sclerosis Treatments

Global MS Market Overview

The global MS therapeutics market, valued at approximately $21 billion in 2022 (source: GlobalData), is projected to expand at a compound annual growth rate (CAGR) of about 5-6% through 2028. The increasing prevalence of MS, driven by aging populations and improved diagnostic methods, underpins this growth. North America dominates due to a high diagnosis rate, while Europe and Asia-Pacific see rising adoption.

Treatment Paradigm and Therapeutic Options

The MS treatment landscape features multiple drug classes:

• Injectable therapies: Interferons, glatiramer acetate.
• Oral therapies: Fingolimod (Gilenya), dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity).
• Infusions: Ocrelizumab (Ocrevus), natalizumab.
• Emerging therapies: Siponimod, ponesimod, cladribine.

Oral agents like ZEPOSIA benefit from patient preference for convenience and ease of administration, gaining rapid market share following approval.

ZEPOSIA’s Market Entry and Positioning

Regulatory Milestones

After FDA approval, ZEPOSIA received the European Commission’s approval in 2021. Its indication spans relapsing MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

Clinical Profile and Differentiators

ZEPOSIA’s key differentiators include:

• Selective S1P receptor modulation: Reduced cardiovascular risks compared to fingolimod.
• Efficacy profile: Demonstrates significant reductions in annualized relapse rates and radiographic disease progression.
• Safety and tolerability: Favorable safety profile with reduced cardiac monitoring requirements.

Distribution and Adoption

As of mid-2023, ZEPOSIA’s adoption remains gradually increasing. The drug has penetrated approximately 8-10% of the oral MS therapy market segment, competing primarily with fingolimod and dimethyl fumarate. The roll-out has been supported by targeted marketing, physician education, and patient access programs.

Market Drivers and Constraints

Drivers

• Patient preference for oral DMTs: The convenience of oral therapy remains a critical driver.
• Growing MS prevalence: Epidemiological data indicate increasing MS diagnoses globally.
• Regulatory support: Expanded indications and favorable safety profiles enhance market potential.
• Competitive positioning: ZEPOSIA’s favorable safety profile appeals to patients and clinicians cautious of fingolimod’s cardiac risks.

Constraints

• Competitive saturation: Established therapies like Gilenya (fingolimod) dominate with deeper market penetration.
• Pricing and reimbursement: Cost considerations and formulary placements influence adoption.
• Market skepticism: Long-term safety and comparative efficacy data remain under scrutiny, influencing prescribing habits.
• Regulatory hurdles: Future approvals, especially for broader indications, hinge on positive trial outcomes.

Financial Trajectory and Revenue Outlook

Current Revenue Performance

In its first two fiscal years post-launch, ZEPOSIA’s revenue grew steadily:

• 2020: Approximately $150 million.
• 2021: Increased to about $400 million.
• 2022: Approached $600 million globally, reflecting robust uptake mainly in the US and Europe.

This growth has been driven by increased patient conversion, expanded indications, and market acceptance.

Forecasted Growth and Market Share

Analysts project ZEPOSIA’s global revenues to surpass $1.2 billion by 2025, assuming continued market penetration and expansion into secondary progressive MS (SPMS). The compound annual growth rate (CAGR) over the next three years is estimated at 20-25%, contingent on:

• Regulatory approvals in additional markets.
• Successful positioning against competing oral therapies.
• Strategic partnerships and payor negotiations.

Revenue Risks and Opportunities

Risks:

• Competitive pressures from emerging S1P modulators (e.g., ponesimod, siponimod).
• Pricing constraints and reimbursement hurdles.
• Potential safety concerns emerging from post-marketing data.

Opportunities:

• Expansion into SPMS and other MS subtypes.
• Combination regimens for more complex cases.
• Broader global access, especially in Asia and Latin America.

Regulatory and Market Expansion Strategies

Bristol-Myers Squibb actively pursues regulatory filings in additional territories and indications. The upcoming pivotal trials, such as phase 3 studies in SPMS, hold promise for broader market access. Strategic collaborations and patient advocacy initiatives support global adoption.

Competitive Dynamics

Key Competitors

• Gilenya (fingolimod): Market leader with over a decade of established presence.
• Aubagio (teriflunomide): Differentiated by mechanistic profile.
• Ponvory (ponesimod): A newer S1P modulator with promising data.
• Ozanimod’s Edge: Differentiated safety profile and ease of titration favor its positioning.

Market Challenges

Overcoming entrenched market dominance and addressing safety concerns remain pivotal. The therapeutic landscape is rapidly evolving with biosimilars and novel mechanisms, demanding continuous innovation and evidence generation.

Key Takeaways

• ZEPOSIA’s market trajectory benefits from growing MS prevalence and patient demand for oral therapies.
• Its differentiated safety and tolerability profile provide a competitive edge over existing S1P modulators.
• Revenue growth is projected to accelerate, with potential to surpass $1.2 billion globally by 2025.
• Market expansion hinges on successful regulatory approvals, competitive positioning, and reimbursement negotiations.
• The drug faces competitive pressures from both established therapies and emerging entrants; strategic investments are essential for sustained growth.

Conclusion

ZEPOSIA’s financial prospects appear strong within the expanding MS therapeutics market, driven by its unique clinical profile and strategic market positioning. While challenges persist from intense competition and pricing pressures, ongoing clinical development and global expansion initiatives position ZEPOSIA as a significant contributor to Bristol-Myers Squibb’s oncology and neurotherapeutics portfolio.

FAQs

1. How does ZEPOSIA differ from other S1P receptor modulators?
ZEPOSIA offers a highly selective S1P receptor modulation with a favorable safety profile, especially regarding cardiovascular risks. Its titration schedule and minimal requirement for cardiac monitoring improve patient convenience.

2. What is the current global market outlook for ZEPOSIA?
The drug is projected to achieve over $1.2 billion in annual revenues by 2025, driven by increasing approvals and expanding indications.

3. What are the primary barriers to ZEPOSIA’s market growth?
Market share growth faces competition from established therapies like Gilenya, cost and reimbursement constraints, and residual safety concerns.

4. Are there upcoming clinical trials that could affect ZEPOSIA’s market position?
Yes, phase 3 trials in secondary progressive MS (SPMS) and broader indications could facilitate regulatory approvals and market expansion.

5. How does ZEPOSIA’s safety profile influence its market adoption?
Its improved safety profile relative to fingolimod encourages prescribing, especially among patients with cardiovascular risk factors, enhancing its competitive appeal.

References

1. GlobalData, “MS Therapeutics Market Analysis,” 2022.
2. Bristol-Myers Squibb, ZEPOSIA Prescribing Information, 2022.
3. FDA, ZEPOSIA (ozanimod) approval announcement, 2020.
4. IQVIA MAT Data, Global MS Market, 2022.