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Last Updated: February 23, 2024

Albuterol sulfate - Generic Drug Details


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What are the generic sources for albuterol sulfate and what is the scope of patent protection?

Albuterol sulfate is the generic ingredient in seventeen branded drugs marketed by Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in one hundred NDAs. There are thirty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has five hundred and sixteen patent family members in thirty-two countries.

There are eleven drug master file entries for albuterol sulfate. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for albuterol sulfate

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Drug Sales Revenue Trends for albuterol sulfate

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Recent Clinical Trials for albuterol sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bond Avillion 2 Development LPPhase 3
ParexelPhase 3
Aurobindo Pharma LtdPhase 3

See all albuterol sulfate clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 0.083% BASE;0.017%SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for albuterol sulfate
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROVENTIL-HFA Inhalation Aerosol albuterol sulfate 0.09 mg base per actuation 020503 1 2015-05-20
PROAIR HFA Inhalation Aerosol albuterol sulfate 0.09 mg base per actuation 021457 1 2012-05-18
ACCUNEB Inhalation Solution albuterol sulfate 0.021% 020949 1 2005-10-19
ACCUNEB Inhalation Solution albuterol sulfate 0.042% 020949 1 2004-04-06

US Patents and Regulatory Information for albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Copley Pharm ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 073307-001 Nov 27, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Therap ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072450-001 Dec 5, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for albuterol sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering PROVENTIL albuterol sulfate TABLET;ORAL 017853-002 May 7, 1982 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 ⤷  Try a Trial ⤷  Try a Trial
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-002 Jan 14, 1987 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.