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.
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
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.23MG BASE | ||||
| Approval Date: | Mar 25, 2020 | TE: | 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: | Aug 30, 2027 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING TO INCLUDE RESULTS FROM A STUDY TO FULFILL POSTMARKETINGREQUIREMENT 3809-5 | ||||||||
| Regulatory Exclusivity Expiration: | Mar 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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