You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

~ Buy the ZEPOSIA (ozanimod hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

ZEPOSIA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Zeposia patents expire, and when can generic versions of Zeposia launch?

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

This drug has one hundred and sixty-two patent family members in thirty-three 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 was eligible for patent challenges on March 25, 2024.

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

< Available with Subscription >

  Sign Up

Summary for ZEPOSIA
International Patents:162
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 1
Patent Applications: 6
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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) IN ADULTS


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

Modulators of sphingosine phosphate receptors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulators of sphingosine phosphate receptors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
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 Y Y ⤷  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 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
Patent: Novel modulators of sphingosine phosphate receptors
Estimated Expiration: ⤷  Sign Up

Patent: 15213309
Patent: NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0912545
Patent: novos moduladores de receptores de esfingosina fosfato
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 23904
Patent: NOUVEAUX MODULATEURS DES RECEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2118972
Patent: Novel modulators of sphingosine phosphate receptors
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150982
Estimated Expiration: ⤷  Sign Up

Patent: 0201316
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 23338
Estimated Expiration: ⤷  Sign Up

Patent: 20033
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 91080
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1672
Patent: МОДУЛЯТОРЫ РЕЦЕПТОРОВ СФИНГОЗИН-1-ФОСФАТА И ИХ ПРИМЕНЕНИЕ (MODULATORS OF SPHINGOSINE-1-PHOSPHATE RECEPTORS AND USE THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 1001785
Patent: МОДУЛЯТОРЫ РЕЦЕПТОРОВ СФИНГОЗИН-1-ФОСФАТА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 91080
Patent: NOUVEAUX MODULATEURS DES RÉCEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Patent: NOUVEAUX MODULATEURS DE RÉCEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Patent: 82991
Patent: NOUVEAUX MODULATEURS DE RÉCEPTEURS DE LA SPHINGOSINE PHOSPHATE (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0200037
Estimated Expiration: ⤷  Sign Up

Patent: 91080
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25984
Estimated Expiration: ⤷  Sign Up

Patent: 50411
Estimated Expiration: ⤷  Sign Up

Patent: 000038
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9306
Patent: תרכובות 1, 2, 4- אוקסדיאזול כמודולטורים של רצפטורים של ספינגוסין פוספאט (1, 2, 4- oxadiazole compounds as modulators of sphingosine phosphate receptors)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 37417
Estimated Expiration: ⤷  Sign Up

Patent: 11523412
Estimated Expiration: ⤷  Sign Up

Patent: 16041736
Patent: スフィンゴシンリン酸受容体の新規なモジュレーター (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 291080
Estimated Expiration: ⤷  Sign Up

Patent: 2020529
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 6381
Patent: NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS
Estimated Expiration: ⤷  Sign Up

Patent: 2105
Patent: NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10012461
Patent: MODULADORES NOVEDOSOS DE RECEPTORES DE FOSFATO DE ESFINGOSINA. (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1065
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

Poland

Patent: 91080
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 91080
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 91080
Estimated Expiration: ⤷  Sign Up

Patent: 13326
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1007804
Patent: NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1582910
Estimated Expiration: ⤷  Sign Up

Patent: 110010777
Patent: NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS
Estimated Expiration: ⤷  Sign Up

Patent: 150064245
Patent: 스핑고신 포스페이트 수용체의 신규한 모듈레이터 (NOVEL MODULATORS OF SPHINGOSINE PHOSPHATE RECEPTORS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 49761
Estimated Expiration: ⤷  Sign Up

Patent: 13368
Estimated Expiration: ⤷  Sign Up

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
Poland 2291080 ⤷  Sign Up
Lithuania 2913326 ⤷  Sign Up
Brazil 112012011430 moduladores de receptor de esfingosina 1 fosfato e métodos de síntese quiral ⤷  Sign Up
Croatia P20210446 ⤷  Sign Up
China 102118972 Novel modulators of sphingosine phosphate receptors ⤷  Sign Up
Finland 2291080 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPOSIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2291080 C02291080/01 Switzerland ⤷  Sign Up PRODUCT NAME: OZANIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67046 11.08.2020
2498610 PA2020533 Lithuania ⤷  Sign Up PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520
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 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
2291080 40/2020 Austria ⤷  Sign Up PRODUCT NAME: OZANIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE OZANIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/20/1442 (MITTEILUNG) 20200525
2498610 2020C/544 Belgium ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.