Orange Book product · Brand (NDA)

XIPERE

TRIAMCINOLONE ACETONIDE

Brand (NDA)NDA 211950RX BAUSCH AND LOMB INC

Oct 22, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 22, 2021
4 yr 9 mo ago
Today
Patent 8636713 expires
Listed method-of-use patent (U-3234) expiration.
May 02, 2027
in 11 mo
Patent 9636332 expires
Listed method-of-use patent (U-3234) expiration.
Nov 08, 2033
in 7 yr 6 mo
Patent 9937075 expires
Listed drug product patent expiration.
May 02, 2034
in 8 yr
Patent 12419833 expires
Listed drug product patent expiration.
Apr 16, 2040
in 14 yr

Active ingredient

TRIAMCINOLONE ACETONIDE

Strength

40MG/ML

Dosage form

SUSPENSION

Route

INJECTION

TE code

Not listed

Application

NDA 211950

Product number

001

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
8636713	May 02, 2027	in 11 mo	U-3234
9636332	Nov 08, 2033	in 7 yr 6 mo	U-3234
9937075	May 02, 2034	in 8 yr	Product
12419833	Apr 16, 2040	in 14 yr	ProductU-3234