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Last Updated: January 17, 2021

DrugPatentWatch Database Preview

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 sixteen branded drugs marketed by Cipla, Lupin, Perrigo Pharms Co, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Amneal Pharms Co, Arise, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-eight 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 four hundred and fifty-seven patent family members in thirty-two countries.

There are thirty-eight drug master file entries for albuterol sulfate. Forty-one 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

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SponsorPhase
University of California, IrvinePhase 4
Sun Pharmaceutical Industries LimitedPhase 3
Amneal Ireland LimitedPhase 3

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Generic filers with tentative approvals for ALBUTEROL SULFATE
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.

Pharmacology for albuterol sulfate
Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE
Tradename Dosage Ingredient NDA Submissiondate
PROVENTIL-HFA AEROSOL, METERED;INHALATION albuterol sulfate 020503 2015-05-20
PROAIR HFA AEROSOL, METERED;INHALATION albuterol sulfate 021457 2012-05-18
ACCUNEB SOLUTION;INHALATION albuterol sulfate 020949 2005-10-19
VOLMAX TABLET, EXTENDED RELEASE;ORAL albuterol sulfate 019604
VENTOLIN SYRUP;ORAL albuterol sulfate 019621

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
Mylan Speciality Lp DUONEB albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 020950-001 Mar 21, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Watson Labs Inc ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 076370-001 Nov 24, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-001 Apr 30, 2001 AN RX Yes Yes   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 sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-001 Dec 23, 1992   Start Trial   Start Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001   Start Trial   Start Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001   Start Trial   Start Trial
Glaxosmithkline VENTOLIN ROTACAPS albuterol sulfate CAPSULE;INHALATION 019489-001 May 4, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School

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.