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Last Updated: March 19, 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, 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, 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 six 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
⤷  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.

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
Copley Pharm ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 073495-001 May 28, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074749-001 Jan 30, 1998 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 213657-001 May 14, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 073165-001 Apr 29, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Schering PROVENTIL albuterol AEROSOL, METERED;INHALATION 017559-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline VENTOLIN albuterol AEROSOL, METERED;INHALATION 018473-001 Approved Prior to Jan 1, 1982 ⤷  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.