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Last Updated: August 17, 2022

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 four patents protecting this drug.

This drug has one hundred and forty-six patent family members in thirty 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:146
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 43
Patent Applications: 247
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 Generic Entry Opportunity 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.

US Patents and Regulatory Information for ZEPOSIA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPOSIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Modulators of sphingosine phosphate receptors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of sphingosine phosphate receptors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-002 Mar 25, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Patent: 15213309
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0912545
Estimated Expiration: See Plans and Pricing

Canada

Patent: 23904
Estimated Expiration: See Plans and Pricing

China

Patent: 2118972
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150982
Estimated Expiration: See Plans and Pricing

Patent: 0201316
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 91080
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1672
Estimated Expiration: See Plans and Pricing

Patent: 1001785
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 91080
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

Patent: 82991
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25984
Estimated Expiration: See Plans and Pricing

Patent: 50411
Estimated Expiration: See Plans and Pricing

Patent: 000038
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9306
Estimated Expiration: See Plans and Pricing

Japan

Patent: 37417
Estimated Expiration: See Plans and Pricing

Patent: 11523412
Estimated Expiration: See Plans and Pricing

Patent: 16041736
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 291080
Estimated Expiration: See Plans and Pricing

Patent: 2020529
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6381
Estimated Expiration: See Plans and Pricing

Patent: 2105
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10012461
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1065
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9617
Estimated Expiration: See Plans and Pricing

Poland

Patent: 91080
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 91080
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 91080
Estimated Expiration: See Plans and Pricing

Patent: 13326
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1007804
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1582910
Estimated Expiration: See Plans and Pricing

Patent: 110010777
Estimated Expiration: See Plans and Pricing

Patent: 150064245
Estimated Expiration: See Plans and Pricing

Spain

Patent: 49761
Estimated Expiration: See Plans and Pricing

Patent: 13368
Estimated Expiration: See Plans and Pricing

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 2498611 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011060389 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011060391 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPOSIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498610 132020000000147 Italy See Plans and Pricing PRODUCT NAME: OZANIMOD O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE OZANIMOD CLORIDRATO(ZEPOSIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1442, 20200525
2291080 2020/042 Ireland See Plans and Pricing PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION NO/DATE: EU/1/20/1442 20200525
2291080 CA 2020 00047 Denmark See Plans and Pricing PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORID; REG. NO/DATE: EU/1/20/1442 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.