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 sixty-eight patent family members in thirty-five 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 May 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEPOSIA

International Patents:	168
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	2
Patent Applications:	6
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

8,481,573

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

This potential generic entry date is based on patent 8,481,573.

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	10,239,846
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	209899-003	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	8,481,573		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

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
Malaysia	161854	SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS
European Patent Office	2291080	NOUVEAUX MODULATEURS DES RÉCEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Brazil	112012011430	moduladores de receptor de esfingosina 1 fosfato e métodos de síntese quiral
Portugal	2498609
Eurasian Patent Organization	201001785	МОДУЛЯТОРЫ РЕЦЕПТОРОВ СФИНГОЗИН-1-ФОСФАТА

Supplementary Protection Certificates for ZEPOSIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498610	PA2020533	Lithuania		PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2498610	2020/051	Ireland		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION 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
2498610	C02498610/01	Switzerland		PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2498610	2090047-8	Sweden		PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525

Market Dynamics and Financial Trajectory for ZEPOSIA

Introduction to ZEPOSIA

ZEPOSIA, developed by Bristol Myers Squibb, is a sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of moderate to severe ulcerative colitis (UC). Understanding the market dynamics and financial trajectory of ZEPOSIA is crucial for assessing its current and future impact in the UC treatment landscape.

Mechanism of Action and Clinical Use

ZEPOSIA works by binding to S1P receptors, which affects the circulation of lymphocytes and reduces inflammation in the gastrointestinal tract. This mechanism makes it a unique oral treatment option in a market dominated by biologics and other injectable therapies[1].

Market Positioning

Despite its approval, ZEPOSIA has faced challenges in cementing a strong market position. At 20 months post-FDA approval, physician use of ZEPOSIA remains relatively low, with significant variability in its allocation across different lines of therapy. However, there is a growing trend towards its use in mild to moderate UC cases, indicating potential for future growth[3].

Competition in the UC Market

The UC market is highly competitive, with several biologics and emerging therapies vying for market share. Key competitors include AbbVie’s Humira, J&J’s Stelara, Takeda’s Entyvio, and Eli Lilly’s Olumiant. Recently, Pfizer’s Velsipity, another S1P receptor modulator, has entered the market and is poised to challenge ZEPOSIA’s position[4].

Financial Performance

Bristol Myers Squibb's financial reports provide insights into ZEPOSIA's revenue performance. While the company's overall revenues have shown stability, the specific revenue figures for ZEPOSIA are not explicitly detailed in the public financial reports. However, it is clear that the drug's sales are part of the broader in-line product revenues, which have seen modest growth.

Revenue Projections

Market forecasts indicate that ZEPOSIA's sales are expected to grow over the next decade, driven by increasing demand for oral therapies in the UC market. The report from ResearchAndMarkets projects the ZEPOSIA market size in the seven major markets (7MM) from 2019 to 2032, highlighting potential growth despite competitive pressures[1].

Regulatory Milestones and Development Activities

ZEPOSIA has achieved several regulatory milestones, including FDA approval for UC. The drug's development activities are ongoing, with a focus on expanding its therapeutic indications and improving patient outcomes. The report from ResearchAndMarkets details the regulatory milestones and other developmental activities, which are crucial for maintaining market competitiveness[1].

SWOT Analysis

Strengths

• Oral Administration: ZEPOSIA's oral formulation is a significant advantage over injectable biologics, making it more appealing to patients and physicians seeking convenience and ease of administration[4].
• Mechanism of Action: The S1P receptor modulator mechanism offers a novel approach to treating UC, which can be particularly beneficial for patients who do not respond well to traditional therapies[1].

Weaknesses

• Market Penetration: Despite its approval, ZEPOSIA has yet to achieve significant market penetration, with physicians still determining its optimal positioning in UC treatment protocols[3].
• Competition: The presence of strong competitors, including biologics and other emerging S1P receptor modulators like Velsipity, poses a significant challenge to ZEPOSIA's market share[4].

Opportunities

• Growing Demand for Oral Therapies: There is a growing preference among gastroenterologists for efficacious oral therapies in the pre-biologic space, which presents an opportunity for ZEPOSIA to expand its market share[4].
• Future Indications: Potential expansion into other therapeutic areas or indications could further boost ZEPOSIA's revenue and market presence.

Threats

• Emerging Therapies: The launch of new therapies, such as Pfizer's Velsipity and potentially Pfizer's etrasimod, could significantly impact ZEPOSIA's market position. These therapies may offer better efficacy or safety profiles, attracting physicians and patients away from ZEPOSIA[3][4].
• Market Competition: The highly competitive nature of the UC market means that ZEPOSIA must continuously demonstrate its value and efficacy to maintain and grow its market share.

Analyst Views and Market Forecasts

Analysts view ZEPOSIA as having potential for growth, but it faces stiff competition. According to Spherix Global Insights, physicians see room for ZEPOSIA to grow its market share, but it must overcome existing perceptions and compete effectively against new entrants like Velsipity[3].

Forecasted Sales

The market forecast for ZEPOSIA indicates growth potential, with projected sales increasing over the next decade. However, the exact figures are influenced by various factors, including the launch of competing therapies and changes in physician prescribing habits[1].

Emerging Therapies and Competitive Landscape

The UC market is dynamic, with multiple therapies receiving approvals and several pipeline agents under development. Pfizer's Velsipity, in particular, has shown strong early performance and is expected to challenge ZEPOSIA's market position. Other emerging therapies, such as etrasimod, are also anticipated to play significant roles in future UC management[3][4].

Patient and Physician Preferences

Gastroenterologists are increasingly looking for efficacious oral therapies, which aligns with ZEPOSIA's profile. However, the drug must overcome pre-existing perceptions about S1P receptor modulators to gain wider acceptance. A Pulse survey by Spherix indicated that while some physicians are reluctant to prescribe ZEPOSIA as a first-line agent, there is potential for increased adoption in the near future[3].

Key Takeaways

• Market Position: ZEPOSIA faces challenges in establishing a strong market position despite its unique oral formulation and novel mechanism of action.
• Competition: The UC market is highly competitive, with ZEPOSIA competing against established biologics and emerging therapies like Velsipity.
• Growth Potential: There is room for growth, particularly if ZEPOSIA can address existing perceptions and capitalize on the growing demand for oral therapies.
• Regulatory and Developmental Activities: Ongoing regulatory milestones and development activities are crucial for ZEPOSIA's long-term success.
• Analyst Views: Analysts see potential for ZEPOSIA but highlight the need to overcome competitive pressures and existing market dynamics.

FAQs

Q: What is the mechanism of action of ZEPOSIA?

ZEPOSIA works by binding to S1P receptors, affecting the circulation of lymphocytes and reducing inflammation in the gastrointestinal tract.

Q: How does ZEPOSIA compare to other UC treatments in terms of market share?

ZEPOSIA currently holds a smaller market share compared to established biologics but has the potential to grow, especially if it can overcome existing perceptions and capitalize on the demand for oral therapies.

Q: What are the key competitors to ZEPOSIA in the UC market?

Key competitors include AbbVie’s Humira, J&J’s Stelara, Takeda’s Entyvio, Eli Lilly’s Olumiant, and Pfizer’s Velsipity.

Q: What is the forecasted market scenario for ZEPOSIA?

The market forecast indicates potential growth for ZEPOSIA over the next decade, driven by increasing demand for oral therapies, but it faces significant competition from emerging therapies.

Q: How do physicians view ZEPOSIA as a treatment option for UC?

Physicians see ZEPOSIA as a potential option, particularly for mild to moderate UC cases, but there are still barriers to its widespread adoption, including existing perceptions about S1P receptor modulators.

Sources

1. ResearchAndMarkets, "ZEPOSIA Market Drug Insight and Market Forecast - 2032"
2. Bristol Myers Squibb, "Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022"
3. Spherix Global Insights, "Can BMS' Zeposia Cement a Defensible Market Position in Ulcerative Colitis Ahead of Pfizer's Potential Rival S1P Treatment Etrasimod?"
4. Fierce Pharma, "Pfizer's Velsipity poised to outpace BMS' Zeposia in ulcerative colitis market, but must head off further competition: analysts"