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Last Updated: February 27, 2021

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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, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Muro, Dava Pharms Inc, Aizant, Am Therap, Amneal Pharms Co, 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

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

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

See all ALBUTEROL SULFATE clinical trials

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
VENTOLIN SYRUP;ORAL albuterol sulfate 019621
VOLMAX TABLET, EXTENDED RELEASE;ORAL albuterol sulfate 019604

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
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532-001 Jul 8, 2020 AN RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline VENTOLIN albuterol sulfate SOLUTION;INHALATION 019269-002 Jan 16, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Teva ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072938-001 Mar 30, 1990 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
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
>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 albuterol sulfate SYRUP;ORAL 019621-001 Jun 10, 1987   Start Trial   Start Trial
Schering PROVENTIL albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019383-001 Jul 13, 1987   Start Trial   Start Trial
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001   Start Trial   Start Trial
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-002 Dec 23, 1992   Start Trial   Start Trial
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-002 Jan 14, 1987   Start Trial   Start Trial
Schering PROVENTIL albuterol sulfate TABLET;ORAL 017853-002 May 7, 1982   Start Trial   Start 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.