Viewing data from:

QNASL

NDA

BECLOMETHASONE DIPROPIONATE | N202813 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

10188811

Oct. 21, 2031

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 Qnasl (2023)

Total Spending

$4.8M

Total Claims

10,982

Beneficiaries

2,970

Avg Cost/Unit

$28.31

Spending Trend

$5.5M(2019)→$5.6M(2020)→$5.3M(2021)→$5.1M(2022)→$4.8M(2023)

YoY Change:+5.7%

5yr CAGR:+6.5%

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

API Supply Chain5 active DMFs10 inactive

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

TAPI NL BVBECLOMETHASONE DIPROPIONATE

DMF 48711983

FARMABIOS SPABECLOMETHASONE DIPROPIONATE

DMF 128131998

AMPHASTAR NANJING PHARMACEUTICALS INCBECLOMETHASONE DIPROPIONATE

DMF 278372014

SYMBIOTEC PHARMALAB PRIVATE LTDBECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED)

DMF 281372014

CIPLA LTDBECLOMETHASONE DIPROPIONATE USP (ANHYDROUS)

DMF 289282015

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 60841985

QUATRUMInactiveBECLOMETHASONE DIPROPIONATE

DMF 75011988

ROUSSELL UCLAFInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 80361989

FARMABOISInactiveBECLOMETHASONE DIPROPIONATE

DMF 80761989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE

DMF 139651999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE

DMF 169342003

CIPLA LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 197502006

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 226482008

ALP PHARM BEIJING CO LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 230302009

HOVIONE FARMACIENCIA SAInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE USP

DMF 271962013

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 28, 2017	SUPPL -11	View Letter (PDF)
Dec 18, 2014	SUPPL -7	View Letter (PDF)
Dec 18, 2014	SUPPL -9	View Letter (PDF)
Jul 11, 2014	SUPPL -6	View Letter (PDF)
Mar 20, 2014	SUPPL -5	View Letter (PDF)
Mar 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.08MG/ACTUATION

RLD

1 patent0 exclusivities▴

AEROSOL, METERED;NASAL | Approved: Mar 23, 2012

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10188811	Oct 21, 2031	—	—	Yes	—	—

#002 — 0.04MG/ACTUATION

RLD

1 patent0 exclusivities▾

AEROSOL, METERED;NASAL | Approved: Dec 17, 2014