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Last Updated: March 3, 2024

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ZEPOSIA Drug Patent Profile


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Which patents cover Zeposia, and what generic alternatives are available?

Zeposia is a drug marketed by Celgene Intl and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and sixty patent family members in thirty-two 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 will be eligible for patent challenges on March 25, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

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Summary for ZEPOSIA
International Patents:160
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
Drug patent expirations by year for ZEPOSIA
Drug Prices for ZEPOSIA

See drug prices for ZEPOSIA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEPOSIA
Generic Entry Date for ZEPOSIA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
I.R.C.C.S. Fondazione Santa LuciaPhase 4

See all ZEPOSIA clinical trials

Pharmacology for ZEPOSIA

US Patents and Regulatory Information for ZEPOSIA

ZEPOSIA is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPOSIA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) IN ADULTS

Modulators of sphingosine phosphate receptors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS

Modulators of sphingosine phosphate receptors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of sphingosine phosphate receptors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS

FDA Regulatory Exclusivity protecting ZEPOSIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS
Exclusivity Expiration: ⤷  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
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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

Patent: 09258242
Estimated Expiration: ⤷  Try a Trial

Patent: 15213309
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 42389
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0912545
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 23904
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2118972
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150982
Estimated Expiration: ⤷  Try a Trial

Patent: 0201316
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20033
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1672
Estimated Expiration: ⤷  Try a Trial

Patent: 1001785
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Patent: 04999
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

Patent: 82991
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 0200037
Estimated Expiration: ⤷  Try a Trial

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25984
Estimated Expiration: ⤷  Try a Trial

Patent: 50411
Estimated Expiration: ⤷  Try a Trial

Patent: 000038
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9306
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 37417
Estimated Expiration: ⤷  Try a Trial

Patent: 11523412
Estimated Expiration: ⤷  Try a Trial

Patent: 16041736
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 291080
Estimated Expiration: ⤷  Try a Trial

Patent: 2020529
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6381
Estimated Expiration: ⤷  Try a Trial

Patent: 2105
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10012461
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1065
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9617
Patent: 3-(Inden-4-yl)-5-(phenyl)-1,2,4-oxadiazole and 3-(tetralin-5-yl)-5-(phenyl)-1,2,4-oxadiazole derivatives
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 91080
Estimated Expiration: ⤷  Try a Trial

Patent: 13326
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1007804
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1582910
Estimated Expiration: ⤷  Try a Trial

Patent: 110010777
Estimated Expiration: ⤷  Try a Trial

Patent: 150064245
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 49761
Estimated Expiration: ⤷  Try a Trial

Patent: 13368
Estimated Expiration: ⤷  Try a Trial

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
South Korea 20160149317 선택적인 스핑고신 1 포스페이트 수용체 조절자 및 카이랄 합성 방법 (1 SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYSTHESIS) ⤷  Try a Trial
Poland 2498611 ⤷  Try a Trial
Canada 2723904 NOUVEAUX MODULATEURS DES RECEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS) ⤷  Try a Trial
South Korea 20110010777 NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPOSIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2291080 CA 2020 00047 Denmark ⤷  Try a Trial PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORID; REG. NO/DATE: EU/1/20/1442 20200520
2498610 20C1059 France ⤷  Try a Trial PRODUCT NAME: OZANIMOD OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER CHLORHYDRATE D'OZANIMOD; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2498610 CA 2020 00053 Denmark ⤷  Try a Trial PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525
2291080 301065 Netherlands ⤷  Try a Trial PRODUCT NAME: OZANIMOD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER OZANIMODHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/20/1442 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.