Ozanimod hydrochloride - Generic Drug Details

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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-four patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for ozanimod hydrochloride

International Patents:	164
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	30
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

Generic Entry Date for ozanimod hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Geert D'Haens	Phase 4
I.R.C.C.S. Fondazione Santa Lucia	Phase 4
Bristol-Myers Squibb	Phase 3

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ozanimod hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Canada	2780641	MODULATEURS DE RECEPTEUR DE SPHINGOSINE-1-PHOSPHATE HETEROCYCLIQUES SELECTIFS (SELECTIVE HETEROCYCLIC SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS)	⤷ Sign Up
Singapore	10201407357P	SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS	⤷ Sign Up
Poland	2498610		⤷ Sign Up
Finland	2291080		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ozanimod hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2291080	2020/042	Ireland	⤷ Sign Up	PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2498610	SPC/GB20/058	United Kingdom	⤷ Sign Up	PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REGISTERED: UK EU/1/20/1442(NI) 20200520; UK PLGB 15105/0115 20200520
2291080	C02291080/01	Switzerland	⤷ Sign Up	PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2498610	45/2020	Austria	⤷ Sign Up	PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 (MITTEILUNG) 20200525
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.