Viewing data from:

XHANCE

NDA

FLUTICASONE PROPIONATE | N209022 | PARATEK PHARMACEUTICALS INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

11554229

Feb. 23, 2036

12083270

Apr. 4, 2031

12616806

Feb. 23, 2036

I-940

Mar. 15, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xhance (2023)

Total Spending

$18.5M

Total Claims

23,519

Beneficiaries

7,670

Avg Cost/Unit

$38.44

Spending Trend

$4.0M(2019)→$8.2M(2020)→$12.0M(2021)→$15.6M(2022)→$18.5M(2023)

YoY Change:+5.7%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain26 active DMFs5 inactive

22 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDFLUTICASONE PROPIONATE

DMF 154562001

TAPI NL BVFLUTICASONE PROPIONATE

DMF 157452001

CIPLA LTDFLUTICASONE PROPIONATE USP

DMF 157742001

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE

DMF 163342002

STERLING SPAFLUTICASONE PROPIONATE

DMF 164232003

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE USP

DMF 202122007

FARMABIOS SPAFLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)

DMF 204632007

CORAL DRUGS PVT LTDFLUTICASONE PROPIONATE

DMF 218792008

NEWCHEM SPAFLUTICASONE PROPIONATE MICRONIZED

DMF 222362008

AARTI PHARMALABS LTDFLUTICASONE PROPIONATE USP

DMF 229802009

INDUSTRIALE CHIMICA SRLFLUTICASONE PROPIONATE USP

DMF 234272010

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE INHALATION GRADE

DMF 247912011

LUPIN LTDFLUTICASONE PROPIONATE USP

DMF 299752015

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)

DMF 304172016

GLAXOSMITHKLINEFLUTICASONE PROPIONATE

DMF 315342017

CHONGQING HUAPONT PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE INTERMEDIATE

DMF 327832018

GLAXOSMITHKLINE LLCFLUTICASONE PROPIONATE

DMF 329522018

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS III)

DMF 331722018

TIANJIN TIANYAO PHARMACEUTICALS CO LTDFLUTICASONE PROPIONATE USP

DMF 341262019

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE (CRUDE)

DMF 342732019

SHANDONG SIRUI PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE

DMF 353592021

APOTEX INCFLUTICASONE PROPIONATE USP (MICRONIZED)

DMF 353932020

CORAL DRUGS PRIVATE LTDFLUTICASONE PROPIONATE (PROCESS 1)

DMF 363152021

CURIA SPAIN SAUFLUTICASONE PROPIONATE MICRONIZED

DMF 372972022

BREATHGREEN PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE(MICRONIZED AND NON-MICRONIZED)

DMF 387592023

VAMSI LABS LTDFLUTICASONE PROPIONATE USP

DMF 428122025

SCINOPHARM TAIWAN LTDInactiveFLUTICASONE PROPIONATE

DMF 156862001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFLUTICASONE PROPIONATE EP/BP

DMF 175442004

NEULAND LABORATORIES LTDInactiveFLUTICASONE PROPIONATE PH.EUR

DMF 191152006

MYLAN LABORATORIES LTDInactiveFLUTICASONE PROPIONATE USP

DMF 282642014

VAMSI LABS LTDInactiveFLUTICASONE PROPIONATE EP

DMF 402852024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2024	SUPPL -19	View Letter (PDF)
Jan 23, 2023	SUPPL -17	View Letter (PDF)
Jan 23, 2023	SUPPL -13	View Letter (PDF)
May 3, 2021	SUPPL -11	View Letter (PDF)
May 3, 2021	SUPPL -10	View Letter (PDF)
Apr 24, 2020	SUPPL -9	View Letter (PDF)
Sep 22, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.093MG/SPRAY

RLD

3 patents1 exclusivity▴

SPRAY, METERED;NASAL | Approved: Sep 18, 2017

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11554229	Feb 23, 2036	—	—	—		—
12083270	Apr 4, 2031	—	—	—		—
12616806	Feb 23, 2036	—	—	—	U-4524	—

Exclusivities (1)

Code	Date	Status
I-940	Mar 15, 2027	< 1 year

Change History (2)

Recent changes detected for this application.

MODIFIEDStrength7/1/2026

XHANCE (fluticasone propionate) strength field updated from 0.093MG to 0.093MG/SPRAY, clarifying the per-spray dosage unit on NDA 209022.

Old: 0.093MG

New: 0.093MG/SPRAY

ADDED7/1/2026

PARATEK PHARMS added U.S. Patent 12,616,806 to the Orange Book for XHANCE (fluticasone propionate).

New: New record