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Last Updated: December 3, 2022

Albuterol sulfate - Generic Drug Details


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What are the generic drug 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, 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 Molecular, Chartwell Rx, Cosette, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, 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-seven 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 ninety-six patent family members in thirty-two countries.

There are eleven drug master file entries for albuterol sulfate. Forty 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
Bond Avillion 2 Development LPPhase 3
ParexelPhase 3
Aurobindo Pharma LtdPhase 3

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
Boehringer Ingelheim COMBIVENT albuterol sulfate; ipratropium bromide AEROSOL, METERED;INHALATION 020291-001 Oct 24, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 075358-001 Mar 29, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Watson Labs Teva ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077063-001 Dec 31, 2007 DISCN 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
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
Schering PROVENTIL albuterol sulfate TABLET;ORAL 017853-001 May 7, 1982 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for albuterol sulfate

Country Patent Number Title Estimated Expiration
Taiwan 201617102 Compliance monitoring module for a breath-actuated inhaler See Plans and Pricing
Argentina 028747 DESAGLOMERADOR PARA INHALADOR DE POLVO SECO ACCIONADO POR LA RESPIRACION, UN INHALADOR DE POLVO SECO Y UN METODO DE DESAGLOMERACION DE POLVO SECO. See Plans and Pricing
Australia 2020200884 Compliance monitoring module for a breath-actuated inhaler See Plans and Pricing
Spain 2811842 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.