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Last Updated: September 29, 2020

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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 seventeen branded drugs marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Schering, Glaxosmithkline, Cipla, Perrigo Pharms Co, Teva Branded Pharm, Kindeva, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Amneal Pharms Co, Arise, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in one hundred and one NDAs. There are thirty-seven 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 All Children's HospitalPhase 4
Adamis Pharmaceuticals CorporationPhase 3
University of ArizonaEarly Phase 1

See all albuterol clinical trials

Generic filers with tentative approvals for ALBUTEROL
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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.

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
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 207857-001 Jul 21, 2017 AN RX No No   Start Trial   Start Trial   Start Trial
Copley Pharm ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072966-001 Nov 22, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cosette ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454-001 Sep 25, 1995 AA RX No No   Start Trial   Start Trial   Start 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

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

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