Viewing data from:

PULMICORT RESPULES

NDA

BUDESONIDE | N020929 | ASTRAZENECA PHARMACEUTICALS LP

3 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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

$9.84

per ml

Lowest NADAC/Unit

$4.92

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00186199004PULMICORT 1 MG/2 ML RESPULE	$9.84	ML	Brand	$3.82	2026-04-22
00186198904PULMICORT 0.5 MG/2 ML RESPULE	$4.92	ML	Brand	$0.6926	2026-06-17

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 (3 FSS, 3 Big4)

Lowest Price

$195.62

Highest Price

$612.09

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00186-1988-04PULMICORT RESPULES 0.25MG/2ML AMPULE	$259.85	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-1988-04PULMICORT RESPULES 0.25MG/2ML AMPULE	$195.62	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-1989-04PULMICORT RESPULES 0.5MG/2ML AMPULE	$305.87	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-1989-04PULMICORT RESPULES 0.5MG/2ML AMPULE	$230.25	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-1990-04PULMICORT RESPULES 1.0MG/2ML LIQUID	$612.09	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00186-1990-04PULMICORT RESPULES 1.0MG/2ML LIQUID	$460.64	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

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

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

10 letters from Drugs@FDA

Date	Submission	Document
Sep 9, 2019	SUPPL -52	View Letter (PDF)
Jul 23, 2010	SUPPL -44	View Letter (PDF)
Nov 10, 2009	SUPPL -43	View Letter (PDF)
Jul 5, 2007	SUPPL -32	View Letter (PDF)
Jul 21, 2006	SUPPL -2	View Letter (PDF)
Jul 8, 2005	SUPPL -22	View Letter (PDF)
Sep 26, 2003	SUPPL -15	View Letter (PDF)
Mar 10, 2003	SUPPL -13	View Letter (PDF)
Jan 10, 2003	SUPPL -12	View Letter (PDF)
Aug 8, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.25MG/2ML

RLDAN

0 patents0 exclusivities▴

SUSPENSION;INHALATION | Approved: Aug 8, 2000

No patent or exclusivity listings for this strength.

#002 — 0.5MG/2ML

RLDAN

0 patents0 exclusivities▾

SUSPENSION;INHALATION | Approved: Aug 8, 2000

#003 — 1MG/2ML

RLDAN

0 patents0 exclusivities▾

SUSPENSION;INHALATION | Approved: Aug 8, 2000