Is there a generic for Iberdomide hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iberdomide hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Iberdomide hydrochloride?

ZENBEXUS (NDA 221075, BRISTOL MYERS SQUIBB) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Iberdomide hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Iberdomide hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Iberdomide hydrochloride are approved?

Iberdomide hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Iberdomide hydrochloride

Iberdomide hydrochloride: 1 brand, 0 generics; first approved Aug 13, 2026.

Brand only2 exclusivity periods

Generic status & protection

Marketing exclusivity runs through Aug 13, 2031.

Latest exclusivity ends Aug 13, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

ZENBEXUSRLD
BRISTOL MYERS SQUIBBNDA 22107520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.75MG BASE CAPSULE ORAL Rx —
EQ 1MG BASE CAPSULE ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.75MG BASE	CAPSULE	ORAL	Rx	—
EQ 1MG BASE	CAPSULE	ORAL	Rx	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NCENew chemical entity exclusivity (5 years)
Aug 13, 2031
in 5 yr
NCENew chemical entity exclusivity (5 years)
Aug 13, 2031
in 5 yr

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Aug 13, 2026

1 mo ago

Most recent approval

Aug 13, 2026

1 mo ago

All 1 application were approved in 2026.

Brand (NDA) 1100%

Generic (ANDA) 00%

Iberdomide hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo