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NDA

ALBUTEROL SULFATE | N020949 | PHARMOBEDIENT CONSULTING LLC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MYLAN SPECIALTY L.P. v. AUROBINDO PHARMA USA INC. 3:2018cv15190 1 patentANDA 211888albuterol sulfate	D.N.J.	2018-10-22	Terminated 2019-08-29	—

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

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

3 letters from Drugs@FDA

Date	Submission	Document
May 2, 2022	SUPPL -27	View Letter (PDF)
Mar 7, 2011	SUPPL -24	View Letter (PDF)
Jun 6, 2006	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Apr 30, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INHALATION | Approved: Apr 30, 2001