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 Celgene Intl and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ozanimod hydrochloride has one hundred and fifty-two patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for ozanimod hydrochloride

International Patents:	152
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	28
Patent Applications:	18
What excipients (inactive ingredients) are in ozanimod hydrochloride?	ozanimod hydrochloride excipients list
DailyMed Link:	ozanimod hydrochloride at DailyMed

Recent Clinical Trials for ozanimod hydrochloride

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 3
Bristol-Myers Squibb	Phase 4
Bristol-Myers Squibb	Phase 2/Phase 3

See all ozanimod hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ozanimod hydrochloride

L04AA	Selective immunosuppressants
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
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No			Y	Y
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes
Celgene Intl	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No

International Patents for ozanimod hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20120102704	SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYSTHESIS
Japan	2013510885
World Intellectual Property Organization (WIPO)	2009130042
Poland	2291080
South Korea	20120099070	SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS
Israel	267956	מאפנני קולטן ספינגוסין 1 פוספאט בררנים ושיטות לסינתיזה קיראלית (Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis)

Supplementary Protection Certificates for ozanimod hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498610	2020039	Norway		PRODUCT NAME: OZANIMOD ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, SAERLIG OZANIMODHYDROKLORID; REG. NO/DATE: EU/1/20/1442 20200615
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	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	CA 2020 00047	Denmark		PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORID; REG. 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
2291080	122020000055	Germany		PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 20200520