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Last Updated: November 2, 2024

Albuterol - Generic Drug Details


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What are the generic sources for albuterol and what is the scope of freedom to operate?

Albuterol is the generic ingredient in eighteen branded drugs marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Schering, Glaxosmithkline, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, 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, 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, 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 and eight NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for albuterol. There is one tentative approval for this compound.

Drug Prices for albuterol

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Drug Sales Revenue Trends for albuterol

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Recent Clinical Trials for albuterol

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

SponsorPhase
Johns Hopkins UniversityPhase 3
ParexelPhase 3
Norwegian School of Sport SciencesN/A

See all albuterol clinical trials

Generic filers with tentative approvals for ALBUTEROL
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.

Medical Subject Heading (MeSH) Categories for albuterol

US Patents and Regulatory Information for albuterol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Dash Pharms Natco ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072894-002 Jan 17, 1991 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ritedose Corp ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 214531-002 Dec 28, 2021 AN RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Virtus Pharm ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 211397-001 Oct 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pliva ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072317-001 Dec 5, 1989 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
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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Schering PROVENTIL albuterol AEROSOL, METERED;INHALATION 017559-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Schering PROVENTIL albuterol AEROSOL, METERED;INHALATION 017559-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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