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Last Updated: January 19, 2022

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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, Padagis Us, Sandoz Inc, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch And Lomb, Copley Pharm, Landela Pharm, Luoxin Aurovitas, 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, Strides Pharma, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in ninety-nine NDAs. There are thirty-nine 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-five patent family members in thirty-two countries.

There are thirty-eight drug master file entries for albuterol sulfate. Forty-two 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
Emory UniversityPhase 1
The Marcus FoundationPhase 1
Intech Biopharm Ltd.N/A

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Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it FreeEQ 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
Roxane ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 075129-001 Feb 13, 2001 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074543-001 Jan 15, 1998 AN RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try it Free ⤷  Try it Free
Kindeva PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Try it Free ⤷  Try it Free
Schering PROVENTIL albuterol sulfate TABLET;ORAL 017853-002 May 7, 1982 ⤷  Try it Free ⤷  Try it Free
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 ⤷  Try it Free ⤷  Try it Free
>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.