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Last Updated: May 28, 2022

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, Rising, Muro, Strides Pharma, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Mylan, Pliva, 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-one 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-one patent family members in thirty-two countries.

There are eleven 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
Aurobindo Pharma LtdPhase 3
Wake Forest University Health SciencesEarly Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.Early Phase 1

See all ALBUTEROL SULFATE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 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 Strength NDA ANDAs Submitted Submissiondate
PROVENTIL-HFA Inhalation Aerosol albuterol sulfate 0.09 mg base per actuation 020503 1 2015-05-20
PROAIR HFA Inhalation Aerosol albuterol sulfate 0.09 mg base per actuation 021457 1 2012-05-18
ACCUNEB Inhalation Solution albuterol sulfate 0.021% 020949 1 2005-10-19
ACCUNEB Inhalation Solution albuterol sulfate 0.042% 020949 1 2004-04-06

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
Cosette ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454-001 Sep 25, 1995 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Therap ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072450-001 Dec 5, 1989 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eywa ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 213524-002 Oct 8, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Copley Pharm ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072967-001 Nov 22, 1991 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 AB2 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Appco ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 210948-002 Mar 15, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Schering PROVENTIL albuterol sulfate SYRUP;ORAL 018062-001 Jan 19, 1983 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp ACCUNEB albuterol sulfate SOLUTION;INHALATION 020949-001 Apr 30, 2001 See Plans and Pricing See Plans and Pricing
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-001 Dec 23, 1992 See Plans and Pricing See Plans and Pricing
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-002 Dec 23, 1992 See Plans and Pricing See Plans and Pricing
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 See Plans and Pricing See Plans and Pricing
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 See Plans and Pricing See Plans and Pricing
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ALBUTEROL SULFATE

Country Patent Number Title Estimated Expiration
Australia 2001270113 See Plans and Pricing
Denmark 1667627 See Plans and Pricing
United Kingdom 2365778 Dose metering system for medicament inhaler See Plans and Pricing
Mexico 339742 CONTADORES DE DOSIS PARA INHALADORES, INHALADORES Y FLECHAS DE LOS MISMOS. (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF.) See Plans and Pricing
Japan 2010523184 See Plans and Pricing
Spain 2544278 See Plans and Pricing
Cyprus 1113531 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.