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VENTOLIN HFA

NDA

ALBUTEROL SULFATE | N020983 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

1 strength0 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 Ventolin HFA (2023)

Total Spending

$192.5M

Total Claims

2,628,723

Beneficiaries

956,475

Avg Cost/Unit

$3.37

Spending Trend

$499.8M(2019)→$314.3M(2020)→$195.5M(2021)→$170.3M(2022)→$192.5M(2023)

YoY Change:+1.4%

5yr CAGR:+1.8%

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

API Supply Chain12 active DMFs1 inactive

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

CIPLA LTDALBUTEROL SULFATE USP

DMF 68851987

FDC LTDALBUTEROL SULFATE USP

DMF 78091988

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGALBUTEROL SULFATE (UNMICRONIZED)

DMF 142581999

NEULAND LABORATORIES LTDALBUTEROL SULFATE USP

DMF 163712003

CIPLA LTDALBUTEROL SULFATE USP

DMF 166782003

MELODY HEALTHCARE PVT LTDALBUTEROL SULFATE USP

DMF 265622012

LUSOCHIMICA SPAALBUTEROL SULFATE

DMF 289972015

SUPRIYA LIFESCIENCE LTDALBUTEROL SULFATE USP

DMF 307082016

PEARL THERAPEUTICS INCALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBO

DMF 319952017

OLON SPAALBUTEROL SULFATE

DMF 341752020

LUPIN LTDALBUTEROL SULFATE

DMF 396822024

VAMSI LABS LTDALBUTEROL SULFATE USP

DMF 425932025

NEULAND LABORATORIES LTDInactiveALBUTEROL SULFATE

DMF 102541993

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2021	SUPPL -41	View Letter (PDF)
Dec 19, 2019	SUPPL -36	View Letter (PDF)
Dec 23, 2014	SUPPL -32	View Letter (PDF)
Sep 7, 2012	SUPPL -27	View Letter (PDF)
Apr 2, 2008	SUPPL -16	View Letter (PDF)
Apr 28, 2005	SUPPL -9	View Letter (PDF)
Apr 19, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH

RLDAB3

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Apr 19, 2001

No patent or exclusivity listings for this strength.