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Last Updated: April 30, 2024

Ozanimod hydrochloride - Generic Drug Details


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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 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
Generic Entry Date for ozanimod hydrochloride*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
I.R.C.C.S. Fondazione Santa LuciaPhase 4
Bristol-Myers SquibbPhase 3
Bristol-Myers SquibbPhase 4

See all ozanimod hydrochloride clinical trials

Pharmacology for ozanimod hydrochloride

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 209899-001 Mar 25, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bristol ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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

Country Patent Number Title Estimated Expiration
Australia 2015213309 NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS ⤷  Try a Trial
China 114957157 奥扎莫德盐酸盐的晶型及其制备方法 (Crystal form of ozanimod hydrochloride and preparation method thereof) ⤷  Try a Trial
Australia 2010319983 Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis ⤷  Try a Trial
Spain 2665461 ⤷  Try a Trial
South Korea 20120094491 SELECTIVE HETEROCYCLIC SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ozanimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2291080 122020000055 Germany ⤷  Try a Trial PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2498610 PA2020533 Lithuania ⤷  Try a Trial PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2498610 2020/051 Ireland ⤷  Try a Trial PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION NO/DATE: EU/1/20/1442 20200520
2291080 C02291080/01 Switzerland ⤷  Try a Trial PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2291080 C202030049 Spain ⤷  Try a Trial PRODUCT NAME: OZANIMOD O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE OZANIMOD; NATIONAL AUTHORISATION NUMBER: EU/1/20/1442; DATE OF AUTHORISATION: 20200520; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1442; DATE OF FIRST AUTHORISATION IN EEA: 20200520
>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.