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Last Updated: September 29, 2020

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ZEPOSIA Drug 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 three patents protecting this drug.

This drug has twenty-seven patent family members in twenty 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.

US ANDA Litigation and 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:27
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Drug Prices: Drug price information for ZEPOSIA
DailyMed Link:ZEPOSIA at DailyMed
Drug patent expirations by year for ZEPOSIA
Drug Prices for ZEPOSIA

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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

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   Start Trial   Start Trial Y Y   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-002 Mar 25, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-003 Mar 25, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-002 Mar 25, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene Intl ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899-001 Mar 25, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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