Orange Book product · Brand (NDA)

BORTEZOMIB

Brand (NDA)NDA 215331DISCN MAIA PHARMS INC

Jul 27, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 27, 2022
3 yr 11 mo ago
Today
Patent 11679119 expires
Listed method-of-use patent (U-3632) expiration.
Sep 23, 2042
in 16 yr 6 mo
Patent 11679119 expires
Listed method-of-use patent (U-3633) expiration.
Sep 23, 2042
in 16 yr 6 mo
Patent 11752164 expires
Listed method-of-use patent (U-3632) expiration.
Sep 23, 2042
in 16 yr 6 mo
Patent 11752164 expires
Listed method-of-use patent (U-3633) expiration.
Sep 23, 2042
in 16 yr 6 mo
Patent 12005069 expires
Listed drug product patent expiration.
Sep 23, 2042
in 16 yr 6 mo

Active ingredient

BORTEZOMIB

Strength

3.5MG/3.5ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215331

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11679119	Sep 23, 2042	in 16 yr 6 mo	U-3632
11679119	Sep 23, 2042	in 16 yr 6 mo	U-3633
11752164	Sep 23, 2042	in 16 yr 6 mo	U-3632
11752164	Sep 23, 2042	in 16 yr 6 mo	U-3633
12005069	Sep 23, 2042	in 16 yr 6 mo	Product