OZANIMOD HYDROCHLORIDE - Generic Drug Details

What are the generic drug 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 seventy-seven patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for OZANIMOD HYDROCHLORIDE

International Patents:	177
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	35
Patent Applications:	126
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OZANIMOD HYDROCHLORIDE
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

Constraining patent/regulatory exclusivity:

8,481,573

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
Fujian Medical University Union Hospital	PHASE2
ChenXiaoChun	PHASE2
Celgene	PHASE3

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	209899-001	Mar 25, 2020		RX	Yes	No	8,796,318		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	11,680,050		Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	10,239,846
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	8,481,573		Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes	8,796,318		Y	Y

International Patents for OZANIMOD HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Portugal	3406142
Eurasian Patent Organization	201690391
Japan	5922027
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
Netherlands	301065
Slovenia	3406142

Supplementary Protection Certificates for OZANIMOD HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2291080	CA 2020 00047	Denmark		PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORID; REG. NO/DATE: EU/1/20/1442 20200520
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	CR 2020 00047	Denmark		PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORID; REG. NO/DATE: EU/1/20/1442 20200525
2291080	301065	Netherlands		PRODUCT NAME: OZANIMOD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER OZANIMODHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2498610	SPC/GB20/058	United Kingdom		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REGISTERED: UK EU/1/20/1442(NI) 20200520; UK PLGB 15105/0115 20200520
2498610	132020000000147	Italy		PRODUCT NAME: OZANIMOD O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE OZANIMOD CLORIDRATO(ZEPOSIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1442, 20200525

Market Dynamics and Financial Trajectory for Ozanimod Hydrochloride

Last updated: July 31, 2025

Introduction

Ozanimod hydrochloride, marketed under the brand name Zeposia, stands as a compelling entrant in the pharmacological landscape, primarily targeting multiple sclerosis (MS) and inflammatory bowel disease (IBD). Developed by Celgene Corporation, a Bristol Myers Squibb (BMS) company, ozanimod exemplifies a personalized immunomodulatory therapy with a distinctive mechanism of action, leveraging sphingosine-1-phosphate (S1P) receptor modulation. This article analyzes the evolving market dynamics shaping ozanimod's financial trajectory, driven by clinical development milestones, regulatory pathways, competitive pressure, and market adoption.

Pharmacological Profile and Therapeutic Indications

Ozanimod is a selective S1P receptor modulator inhibiting lymphocyte egress from lymphoid tissues, reducing neuroinflammation and intestinal immune responses. Its dual indication setup—relapsing forms of multiple sclerosis (RMS) and moderate-to-severe ulcerative colitis (UC)—positions it favorably within the biopharmaceutical pipeline, contrasting with broader-acting therapies like fingolimod.

Approval in the United States (March 2020) for RMS marked a pivotal milestone, followed by regulatory authorizations in the European Union and other markets, expanding its geographic footprint. The drug's favorable safety profile, oral administration, and efficacy promise notable market penetration, supported by ongoing clinical trials extending into Crohn’s disease and other autoimmune conditions.

Market Dynamics

1. Competitive Landscape and Positioning

The MS treatment space is highly competitive, dominated by infused monoclonal antibodies (e.g., ocrelizumab, natalizumab) and oral agents like fingolimod and dimethyl fumarate. Ozanimod’s selective receptor targeting offers opportunities for differentiated positioning due to a potentially lower risk of cardiac and infection-related adverse events.

In UC, ozanimod faces competition from established biologics (vedolizumab, infliximab), small molecules (tofacitinib), and emerging therapies. Its oral delivery offers a significant advantage over injectables, aligning with patient preferences for convenience and compliance.

2. Clinical Trial Progress and Pipeline Expansion

Clinical developments are critical. Phase III trials (SUNBEAM and RADIANCE) demonstrated ozanimod's efficacy comparable to existing therapies, supporting regulatory approvals. Ongoing studies explore additional indications like Crohn’s disease and systemic sclerosis, positioning ozanimod for future market expansion.

3. Regulatory and Reimbursement Trends

Regulatory support, including FDA approval based on robust Phase III data, reinforces market confidence. Payer acceptance hinges on demonstrated cost-effectiveness, which is emerging as pivotal amid escalating drug prices. Cost-sharing, insurance policies, and value-based agreements will influence reimbursement trajectories.

4. Manufacturing and Supply Chain Considerations

Manufacturing capacity and supply chain robustness undergird supply security and market availability. BMS’s investment in scalable production facilities mitigates risks of shortages that could hamper market growth.

5. Pricing Strategies and Market Penetration

Pricing reflects the competitive landscape, therapeutic value, and healthcare system budgets. As an oral therapy with proven efficacy, ozanimod's pricing is positioned at a premium, balanced against its convenience advantage. Differentiation through value-added services and patient support programs enhances market adoption prospects.

Financial Trajectory

1. Revenue Projections

Following its 2020 launch, ozanimod generated approximately $300 million in 2022 (per financial reports), with projections estimating it could reach $1 billion globally by 2025, contingent on market uptake and approval in additional indications.

2. Growth Drivers

Key drivers include expanding indications, geographic penetration, increased market acceptability, and favorable clinical outcomes. The adoption rate among neurologists and gastroenterologists, supported by evidence-based guidelines, influences revenue.

3. Market Challenges

Challenges such as patent expiration, biosimilar competition, and evolving payer policies threaten revenue streams. Additionally, safety signals or adverse events could impact patient acceptance and reimbursement.

4. Strategic Initiatives

BMS’s strategic focus on evidence expansion, digital engagement, and patient-centric programs are designed to sustain growth momentum. Collaborations with payers and healthcare providers further enhance market access.

5. Long-term Outlook

The long-term financial trajectory depends on successful pipeline expansion and the ability to sustain a competitive edge in a rapidly evolving therapeutic landscape. The ongoing clinical trials and subsequent label expansions are anticipated to provide new revenue streams.

Market Opportunities and Challenges

Opportunities

• Expansion into Underpenetrated Markets: Developing regions with rising prevalence of MS and UC present substantial growth prospects.
• Pipeline Diversification: Development in other autoimmune diseases broadens risk diversification and revenue reservoirs.
• Technological Innovation: Digital health tools for patient monitoring can improve adherence and therapeutic outcomes, indirectly boosting sales.

Challenges

• Intense Competition: Saturation in MS and IBD markets may limit growth curves.
• Pricing Pressures: Payer scrutiny over high drug costs could restrict reimbursement and market penetration.
• Regulatory Hurdles: Future approvals may be delayed or denied based on safety or efficacy concerns.

Regulatory Landscape and Its Impact

Regulatory approvals in key markets affirm ozanimod's safety and efficacy, yet dynamic regulatory landscapes, particularly concerning safety surveillance, may influence labeling and marketing strategies. Post-marketing commitments can impact compliance costs and market confidence.

Key Factors Influencing Market and Financial Outcomes

• Clinical Data Quality: Higher efficacy and safety profiles drive physician preference and payer willingness to reimburse.
• Market Education: Effective dissemination of clinical benefits supports adoption.
• Healthcare System Dynamics: Budget constraints and policy reforms impact drug inclusion and reimbursement rates.
• Innovation and Competition: Novel therapies or biosimilars could erode market share.

Conclusion

Ozanimod hydrochloride's market and financial outlook embodies a nuanced interplay of clinical validation, market positioning, regulatory approval, and competitive dynamics. Its strong initial approval, promising safety profile, and oral administration establish a solid foundation. Continued clinical development, strategic positioning, and navigating payer landscapes are vital for sustainable growth.

Key Takeaways

• Ozanimod’s targeted mechanism and oral formulation confer competitive advantages in MS and UC markets.
• The expanding indications and geographies are central to broadening its revenue base.
• Market penetration hinges on clinical outcomes, payer acceptance, and strategic engagement.
• Competition and pricing pressures demand continuous differentiation and cost-effectiveness demonstrations.
• Long-term growth depends on pipeline success and adaptability within evolving regulatory and healthcare environments.

FAQs

1. What distinguishes ozanimod from other S1P receptor modulators?
Ozanimod selectively targets S1P receptor subtypes 1 and 5, potentially offering a better safety profile and reduced cardiac risks relative to fingolimod, which has broader receptor activity. This selectivity aims to reduce adverse events while maintaining efficacy.

2. How has regulatory approval influenced ozanimod’s market prospects?
Regulatory approvals, notably by the FDA and EMA, validate its efficacy and safety, facilitating market entry. Approval accelerates adoption by clinicians and supports reimbursement negotiations, thereby enhancing revenue potential.

3. What are the key factors impacting ozanimod’s adoption in the UC market?
The oral route provides a convenience advantage, and clinical trial results demonstrate comparable efficacy to biologics, positively influencing physician prescribing habits. Reimbursement policies and safety data further shape adoption.

4. How does competition affect ozanimod’s financial trajectory?
Intense competition from biologics and other small molecules limits growth potential. Market share gains depend on clinical performance, safety profile, patient preferences, and pricing strategies.

5. What is the outlook for ozanimod’s pipeline and future indications?
Ongoing trials explore Crohn’s disease and other autoimmune conditions, offering potential for expanded indications. Success in these areas would diversify revenue streams and bolster long-term growth.

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Sources
[1] Bristol Myers Squibb. "Zeposia (ozanimod) Prescribing Information." 2020.
[2] ClinicalTrials.gov. "Ozanimod Clinical Trials." Accessed 2023.
[3] Company Financial Reports. Bristol Myers Squibb, 2022.
[4] European Medicines Agency. "Zeposia (ozanimod) approval." 2021.
[5] Market Analysis Reports. GlobalData, 2023.