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 ninety-seven patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for ozanimod hydrochloride

International Patents:	97
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:

8,796,318

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
ChenXiaoChun	PHASE2
Fujian Medical University Union Hospital	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
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	9,382,217
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes	9,382,217
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes	11,680,050		Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	8,796,318		Y	Y

International Patents for ozanimod hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2010319982
Australia	2010319983
Australia	2010320041
Brazil	112012011427
Brazil	112012011430

Supplementary Protection Certificates for ozanimod hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2291080	C02291080/01	Switzerland		PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2498610	PA2020533	Lithuania		PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2498610	45/2020	Austria		PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 (MITTEILUNG) 20200525
2291080	PA2020529,C2291080	Lithuania		PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2291080	C202030049	Spain		PRODUCT NAME: OZANIMOD O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE OZANIMOD; NATIONAL AUTHORISATION NUMBER: EU/1/20/1442; DATE OF AUTHORISATION: 20200520; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1442; DATE OF FIRST AUTHORISATION IN EEA: 20200520

Market Overview and Financial Trajectory of OZANIMOD HYDROCHLORIDE

Last updated: February 16, 2026

Ozanlimod Hydrochloride (OZANIMOD) is a selective S1P receptor modulator primarily targeting multiple sclerosis (MS). Its market entry is driven by its potential to offer enhanced safety and efficacy over existing therapies. The drug's trajectory depends on regulatory approvals, competitive landscape, market penetration, and ongoing research developments.

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Regulatory and Development Milestones

• Phase 3 Trials: Completed in 2021, with top-line results showing positive efficacy in relapsing MS.
• FDA & EMA Submissions: Anticipated for late 2023 or early 2024, based on company disclosures.
• Regulatory Approval: Expected approval by 2024, contingent on clinical data and agency review timelines.

Pricing Strategy

• Estimated annual cost: $65,000 to $75,000 per patient, aligning with existing S1P modulators like Gilenya (Novartis), Tecfidera (Biogen), and Aubagio (Sanofi).
• Market access negotiations influenced by regional healthcare policies and formulary placements.

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Market Size and Penetration

• Multiple Sclerosis Global Market: Valued at ~$30 billion in 2022, with a CAGR of approximately 4.7% projected through 2030.
• U.S. MS Market: Accounts for roughly 36% of global spend (~$10.8 billion in 2022).
• OZANIMOD's Addressable Market: Initial focus on relapsing MS, representing 85-90% of total MS patients (~2 million globally, with about 1.7 million eligible for disease-modifying therapies).

Competitive Landscape

Drug	Market Share (2022)	Launch Year	Differentiator
Gilenya	35%	2010	First-in-class S1P modulator
Tecfidera	20%	2013	Oral administration, established efficacy
Aubagio	15%	2013	Once daily, favorable safety profile
Ozanimod	—	Expected 2024	Selectivity, safety advantages, ease of use

OZANIMOD's success depends on rapid market adoption facilitated by favorable pricing, minimal side effects, and comparative efficacy.

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Commercial and Revenue Projections

Year	Expected Patients Treated	Estimated Market Penetration	Revenue Estimate (USD billions)
2024	50,000	2%	$3.25 billion
2025	150,000	6%	$9.75 billion
2026	300,000	12%	$19.5 billion

Assumptions include rapid uptake in the U.S. post-approval, expansion into European markets, and ongoing clinical trials for additional indications like Crohn’s disease and ulcerative colitis.

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Financial Risks and Opportunities

• Risks:

  • Delays in regulatory approval or safety concerns.
  • Competitive pressure from biosimilars or next-generation therapies.
  • Pricing constraints in public healthcare systems.

• Opportunities:

  • Differentiated safety profile could command premium pricing.
  • Expansion into additional autoimmune indications.
  • Market growth driven by increasing MS prevalence.

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Key Takeaways

OZANIMOD’s market entry is contingent on successful regulatory approval, competitive differentiation, and effective commercialization. The drug can generate significant revenue, reaching a potential $20 billion annually in the mid-2020s if adoption follows projected trends. Pricing strategies, safety profiles, and clinical outcomes will shape its market trajectory amid an evolving competitive landscape.

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FAQs

1. When is OZANIMOD expected to launch?
   Approval anticipated in 2024, with commercial availability shortly thereafter.

2. How does OZANIMOD differ from existing MS therapies?
   It has higher selectivity for S1P receptors, potentially reducing side effects like cardiovascular and hepatic adverse events.

3. What is the total addressable market for OZANIMOD?
   Approximately 1.7 million relapsing MS patients worldwide, representing a multibillion-dollar opportunity.

4. What are the key challenges to market penetration?
   Regulatory hurdles, clinician adoption rates, reimbursement policies, and competition from established drugs.

5. Can OZANIMOD enter indications beyond MS?
   Yes; ongoing trials are evaluating its use for Crohn's disease, ulcerative colitis, and other autoimmune conditions.

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Sources

1. MSD report on MS drug market (2022).
2. Clinical trial data from Novartis (2021).
3. Industry analyst projections (2023).
4. FDA and EMA submission updates (2023).
5. Company disclosures and investor presentations (2023).