Viewing data from:

PULMICORT FLEXHALER

NDA

BUDESONIDE | N021949 | CHEPLAPHARM ARZNEIMITTEL GMBH

2 strengths0 unique patents0 unique exclusivities

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

340 trials from ClinicalTrials.gov — 4 recruiting, 2 active, 261 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation NCT03250975	Phase 1/2	Active	Vanderbilt University Medical Center	64	2017-08-19 → 2026-12-30
Epigenetic Health Benefits of Budesonide NCT04342039	Phase 4	Active	University of British Columbia	20	2021-01-07 → 2027-12-31
Diesel Exhaust Induces Glucocorticoid Resistance NCT03615742	Phase 4	Recruiting	University of British Columbia	30	2018-12-01 → 2025-12-31
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients NCT03803787	Phase 2	Recruiting	Instituto Nacional de Cancerologia de Mexico	72	2018-09-01 → 2027-12-01
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis NCT04314375	Phase 4	Recruiting	Bausch Health Americas, Inc.	70	2023-09-29 → 2027-06
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults NCT00242411	Phase 4	Completed	AstraZeneca	1,900	2004-09 → 2006-10
Study to Detect Oral Administration of Budesonide in Women.NCT03537326	Phase 1	Completed	Parc de Salut Mar	4	2018-05-22 → 2018-09-10
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.NCT02149199	Phase 3	Completed	AstraZeneca	3,850	2014-07-07 → 2017-08-02
Effect of Symbicort on GR Localisation in Asthma NCT00159263	N/A	Completed	Imperial College London	10	2004-11 → 2006-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$253.50

per ea

Lowest NADAC/Unit

$188.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61269051812PULMICORT 180 MCG FLEXHALER	$253.50	EA	Brand	—	2026-01-21
61269050906PULMICORT 90 MCG FLEXHALER	$188.52	EA	Brand	—	2026-01-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (4 FSS, 2 Big4)

Lowest Price

$146.63

Highest Price

$246.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61269-0509-06PULMICORT FLEXHALER 90MCG 60 DOSES	$184.26	FSS	H2-Pharma, LLC	10/01/2026
61269-0509-06PULMICORT FLEXHALER 90MCG 60 DOSES	$146.63	Big4	H2-Pharma, LLC	10/01/2026
61269-0518-12PULMICORT FLEXHALER 180MCG/INHL 120 DOSES	$246.77	FSS	H2-Pharma, LLC	10/01/2026
61269-0518-12PULMICORT FLEXHALER 180MCG/INHL 120 DOSES	$196.02	Big4	H2-Pharma, LLC	10/01/2026
85612-0010-01BUDESONIDE 90MCG/INHL INHL,ORAL,60	$146.63	FSS	Allegis Holdings, LLC	08/14/2028
85612-0011-01BUDESONIDE 180MCG/INHL INHL,ORAL,60	$196.02	FSS	Allegis Holdings, LLC	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Pulmicort Flexhaler (2024)

Total Spending

$38.9M

Total Claims

121,500

Beneficiaries

47,043

Avg Cost/Unit

$237.59

Spending Trend

$50.1M(2019)→$54.4M(2020)→$52.2M(2021)→$46.9M(2022)→$41.8M(2023)→$38.9M(2024)

YoY Change:-5.1%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain25 active DMFs4 inactive

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

ASPEN OSS BVBUDESONIDE

DMF 104931993

TAPI NL BVBUDESONIDE

DMF 109761994

TAPI NL BVBUDESONIDE

DMF 169322003

FARMABIOS SPABUDESONIDE

DMF 189102005

CURIA SPAIN SAUBUDESONIDE STERILE MICRONIZED

DMF 195282006

INDUSTRIALE CHIMICA SRLBUDESONIDE USP

DMF 200102006

AARTI PHARMALABS LTDBUDESONIDE USP

DMF 206092007

STERLING SPABUDESONIDE

DMF 226412009

NEWCHEM SPABUDESONIDE MICRONIZED

DMF 253192011

FARMABIOS SPABUDESONIDE MICRONIZED STERILE

DMF 256152011

CURIA SPAIN SAUBUDESONIDE MICRONIZED

DMF 256292011

SUN PHARMACEUTICAL INDUSTRIES LTDBUDESONIDE USP

DMF 264452013

APOTEX INCBUDESONIDE USP

DMF 274512013

CIPLA LTDBUDESONIDE USP

DMF 274612014

MINAKEMBUDESONIDE MICRONIZED

DMF 284412014

CORAL DRUGS PRIVATE LTDBUDESONIDE

DMF 305342017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBUDESONIDE USP BULK API

DMF 321952017

ASTRAZENECA PHARMACEUTICAL LPBUDESONIDE

DMF 331712018

AMPHASTAR NANJING PHARMACEUTICALS INCBUDESONIDE USP

DMF 337142019

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDBUDESONIDE

DMF 342682019

HENAN LIHUA PHARMACEUTICAL CO LTDBUDESONIDE

DMF 358592021

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND STERILE)

DMF 383732023

CHEMO IBERICA SABUDESONIDE MICRONIZED STERILE

DMF 395042024

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND NON-MICRONIZED)

DMF 396912024

AURISCO PHARMACEUTICAL CO LTDBUDESONIDE

DMF 412332025

FARMABIOS SRLInactiveBUDESONIDE

DMF 130131998

FARMABIOS SPAInactiveBUDESONIDE

DMF 152982001

ELAN PHARMACEUTICAL TECHNOLOGIESInactiveBUDESONIDE NANOCRISTAL COLLOIDAL DISPERSION

DMF 156622001

INDUSTRIALE CHIMICA SRLInactiveBUDESONIDE

DMF 158772002

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 9, 2019	SUPPL -13	View Letter (PDF)
Jul 8, 2010	SUPPL -6	View Letter (PDF)
Jun 19, 2008	SUPPL -4	View Letter (PDF)
Apr 16, 2008	SUPPL -3	View Letter (PDF)
Jul 5, 2007	SUPPL -2	View Letter (PDF)
Feb 23, 2007	SUPPL -1	View Letter (PDF)
Jul 21, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.08MG/INH

RLD

0 patents0 exclusivities▴

POWDER, METERED;INHALATION | Approved: Jul 12, 2006

No patent or exclusivity listings for this strength.

#002 — 0.16MG/INH

RLD

0 patents0 exclusivities▾

POWDER, METERED;INHALATION | Approved: Jul 12, 2006