Orange Book product · Brand (NDA)

XHANCE

FLUTICASONE PROPIONATE

Brand (NDA)NDA 209022RX PARATEK PHARMS

Sep 18, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 18, 2017
8 yr 11 mo ago
Today
Exclusivity ends · I-940
New indication exclusivity (3 years)
Mar 15, 2027
in 9 mo
Patent 12083270 expires
Listed method-of-use patent (U-2133) expiration.
Apr 04, 2031
in 4 yr 10 mo
Patent 11554229 expires
Listed method-of-use patent (U-2133) expiration.
Feb 23, 2036
in 9 yr 10 mo
Patent 12616806 expires
Listed method-of-use patent (U-4524) expiration.
Feb 23, 2036
in 9 yr 10 mo
Patent 12616806 expires
Listed method-of-use patent (U-4525) expiration.
Feb 23, 2036
in 9 yr 10 mo

Active ingredient

FLUTICASONE PROPIONATE

Strength

0.093MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 209022

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
12083270	Apr 04, 2031	in 4 yr 10 mo	U-2133
11554229	Feb 23, 2036	in 9 yr 10 mo	U-2133
12616806	Feb 23, 2036	in 9 yr 10 mo	U-4524
12616806	Feb 23, 2036	in 9 yr 10 mo	U-4525