Viewing data from:

PULMICORT

NDA

BUDESONIDE | N020441 | ASTRAZENECA PHARMACEUTICALS LP

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 (2023)

Total Spending

$222K

Total Claims

687

Beneficiaries

394

Avg Cost/Unit

$4.65

Spending Trend

$202K(2019)→$87K(2020)→$42K(2021)→$64K(2022)→$222K(2023)

YoY Change:-24.2%

5yr CAGR:-7.9%

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

6 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2007	SUPPL -20	View Letter (PDF)
Dec 22, 2003	SUPPL -17	View Letter (PDF)
Nov 5, 2003	SUPPL -16	View Letter (PDF)
Sep 30, 2003	SUPPL -18	View Letter (PDF)
Dec 31, 2001	SUPPL -12	View Letter (PDF)
Oct 8, 1998	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 0.16MG/INH

0 patents0 exclusivities▴

POWDER, METERED;INHALATION | Approved: Jun 24, 1997

No patent or exclusivity listings for this strength.

#003 — 0.32MG/INH

0 patents0 exclusivities▾

POWDER, METERED;INHALATION | Approved: Jun 24, 1997