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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-two patent family members in thirty-three 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:	162
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	1
Patent Applications:	8
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

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
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

Anatomical Therapeutic Chemical (ATC) Classes for ZEPOSIA

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 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.

Patents protecting ZEPOSIA

FDA Regulatory Exclusivity protecting ZEPOSIA

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

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
Slovenia	2498611
Croatia	P20201316
Norway	2020039
World Intellectual Property Organization (WIPO)	2011060391
China	109219597	奥扎莫德的晶型、其盐酸盐的晶型及其制备方法 (CRYSTAL FORM OF OZANIMOD, CRYSTAL FORM OF HYDROCHLORIDE THEREOF, AND PREPARATION METHOD THEREFOR)

Supplementary Protection Certificates for ZEPOSIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2291080	PA2020529,C2291080	Lithuania		PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
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
2498610	122020000063	Germany		PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2498610	301076	Netherlands		PRODUCT NAME: OZANIMOD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER OZANIMODHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/20/1442 20200525