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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 209899


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NDA 209899 describes ZEPOSIA, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ZEPOSIA profile page.

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.
Summary for 209899
Tradename:ZEPOSIA
Applicant:Bristol
Ingredient:ozanimod hydrochloride
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209899
Generic Entry Date for 209899*:
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.

Pharmacology for NDA: 209899
Suppliers and Packaging for NDA: 209899
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899 NDA Celgene Corporation 59572-810 59572-810-07 1 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK
ZEPOSIA ozanimod hydrochloride CAPSULE;ORAL 209899 NDA Celgene Corporation 59572-810 59572-810-97 1 KIT in 1 BLISTER PACK (59572-810-97) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.23MG BASE
Approval Date:Mar 25, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2024
Regulatory Exclusivity Use:FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS
Regulatory Exclusivity Expiration:Mar 25, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:Nov 15, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

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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.