Orange Book product · Brand (NDA)

DAPTOMYCIN

Brand (NDA)NDA 217415RX HIKMA

Jan 30, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 30, 2023
3 yr 5 mo ago
Today
Patent 11759497 expires
Listed drug product patent expiration.
Aug 28, 2038
in 12 yr 4 mo
Patent 12053502 expires
Listed method-of-use patent (U-3981) expiration.
Aug 28, 2038
in 12 yr 4 mo
Patent 12629337 expires
Listed drug product patent expiration.
Jan 09, 2043
in 16 yr 10 mo

Active ingredient

DAPTOMYCIN

Strength

500MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 217415

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
11759497	Aug 28, 2038	in 12 yr 4 mo	Product
12053502	Aug 28, 2038	in 12 yr 4 mo	U-3981
12629337	Jan 09, 2043	in 16 yr 10 mo	Product