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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Pulmicort Flexhaler (2023)

Total Spending

$41.8M

Total Claims

117,698

Beneficiaries

43,954

Avg Cost/Unit

$250.37

Spending Trend

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

YoY Change:+3.6%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2023). 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