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PROAIR HFA

NDA

ALBUTEROL SULFATE | N021457 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D LLC et al v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC et al 2:2023cv20964 6 patentsANDA 211600albuterol sulfate	D.N.J.	2023-10-06	Terminated 2025-07-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Proair HFA (2023)

Total Spending

$1.1M

Total Claims

12,038

Beneficiaries

6,696

Avg Cost/Unit

$8.86

Spending Trend

$327.7M(2019)→$190.2M(2020)→$70.0M(2021)→$35.7M(2022)→$1.1M(2023)

YoY Change:+1.5%

5yr CAGR:+3.1%

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

Medicare Part B Spending

CMS physician-administered drug spending for Albuterol Sulfate (J7613) (2023)

Total Spending

$4.5M

Total Claims

728,535

Beneficiaries

274,607

ASP Price

—

Spending Trend

$31K(2023)→$39K(2023)→$4.5M(2023)

HCPCS: J7613 — Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

8 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2019	SUPPL -36	View Letter (PDF)
Dec 15, 2010	SUPPL -22	View Letter (PDF)
Aug 20, 2010	SUPPL -21	View Letter (PDF)
Sep 17, 2008	SUPPL -13	View Letter (PDF)
Nov 30, 2005	SUPPL -2	View Letter (PDF)
Nov 30, 2005	SUPPL -4	View Letter (PDF)
May 4, 2005	SUPPL -1	View Letter (PDF)
Nov 8, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH

RLDAB2

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Oct 29, 2004

No patent or exclusivity listings for this strength.