Orange Book product · Brand (NDA)

XARACOLL

BUPIVACAINE HYDROCHLORIDE

Brand (NDA)NDA 209511DISCN INNOCOLL PHARMS

Aug 28, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 28, 2020
5 yr 11 mo ago
Today
Patent RE47826 expires
Listed method-of-use patent (U-2949) expiration.
May 20, 2029
in 3 yr
Patent 11746141 expires
Listed drug product patent expiration.
Jan 09, 2033
in 6 yr 8 mo

Active ingredient

BUPIVACAINE HYDROCHLORIDE

Strength

100MG

Dosage form

IMPLANT

Route

IMPLANTATION

TE code

Not listed

Application

NDA 209511

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
RE47826	May 20, 2029	in 3 yr	U-2949
11746141	Jan 09, 2033	in 6 yr 8 mo	Product