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 sixty-two patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for ozanimod hydrochloride

International Patents:	162
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	29
Patent Applications:	14
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

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
I.R.C.C.S. Fondazione Santa Lucia	Phase 4
Bristol-Myers Squibb	Phase 3
Bristol-Myers Squibb	Phase 4

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

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	209899-003	Mar 25, 2020		RX	Yes	Yes			Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes			Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No			Y	Y

International Patents for ozanimod hydrochloride

Country	Patent Number	Title	Estimated Expiration
Lithuania	C2291080
Eurasian Patent Organization	025672	СЕЛЕКТИВНЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ МОДУЛЯТОРЫ РЕЦЕПТОРА СФИНГОЗИН-1-ФОСФАТА (SELECTIVE HETEROCYCLIC SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS)
Hungary	S2000038

Supplementary Protection Certificates for ozanimod hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2291080	20C1047	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	2020C/544	Belgium		PRODUCT NAME: OZANIMOD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE D'OZANIMOD; AUTHORISATION NUMBER AND DATE: EU/1/20/1442 20200525