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Last Updated: November 21, 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 Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Norvium Bioscience, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, 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, Hibrow Hlthcare, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Aiping Pharm Inc, and Watson Labs Teva, and is included in one hundred and two NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.

There are eleven drug master file entries for albuterol sulfate. Forty-five 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
ParexelPhase 3
Bond Avillion 2 Development LPPhase 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
⤷  Sign Up⤷  Sign UpEQ 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
Sun Pharm Industries ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072637-001 Dec 5, 1989 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076867-001 Dec 21, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 207857-001 Jul 21, 2017 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca AIRSUPRA albuterol sulfate; budesonide AEROSOL, METERED;INHALATION 214070-001 Jan 10, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072620-001 Dec 5, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Sign Up ⤷  Sign Up
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-001 Jan 14, 1987 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987 ⤷  Sign Up ⤷  Sign Up
Kindeva PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for albuterol sulfate

Country Patent Number Title Estimated Expiration
Israel 223117 מוני מינון למשאפים ומשאפים ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof) ⤷  Sign Up
Hong Kong 1221920 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2021007154 ⤷  Sign Up
Japan 2016041380 吸入器のための用量カウンタ、吸入器及びそのシャフト (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) ⤷  Sign Up
Portugal 1667627 ⤷  Sign Up
San Marino T201500026 ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.