Details for New Drug Application (NDA): 221075
NDA 221075 describes ZENBEXUS, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ZENBEXUS profile page.
The generic ingredient in ZENBEXUS is iberdomide hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iberdomide hydrochloride profile page.
The generic ingredient in ZENBEXUS is iberdomide hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iberdomide hydrochloride profile page.
Summary for 221075
| Tradename: | ZENBEXUS |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | iberdomide hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 221075
Generic Entry Date for 221075*:
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.
Suppliers and Packaging for NDA: 221075
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZENBEXUS | iberdomide hydrochloride | CAPSULE;ORAL | 221075 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-5700 | 0003-5700-21 | 21 CAPSULE in 1 BOTTLE (0003-5700-21) |
| ZENBEXUS | iberdomide hydrochloride | CAPSULE;ORAL | 221075 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-5710 | 0003-5710-21 | 21 CAPSULE in 1 BOTTLE (0003-5710-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.75MG BASE | ||||
| Approval Date: | Aug 13, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 13, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,529,339 | Patent Expiration: | Sep 30, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | IN COMBINATION WITH DARATUMUMAB AND HYALURONIDASE-FIHJ AND DEXAMETHASONE FOR TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING A PROTEASOME INHIBITOR AND AN IMMUNOMODULATORY AGENT | ||||||||
| Patent: | 8,518,972 | Patent Expiration: | Jun 5, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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