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Last Updated: June 21, 2024

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 seventeen branded drugs marketed by Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Mylan Speciality Lp, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Fosun Pharma, and Watson Labs Teva, and is included in one hundred and one NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.

There are eleven drug master file entries for albuterol sulfate. Forty-five 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
⤷  Sign Up⤷  Sign UpEQ 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
Teva Branded Pharm PROAIR DIGIHALER albuterol sulfate POWDER, METERED;INHALATION 205636-002 Dec 21, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aurobindo Pharma Ltd ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 213657-001 May 14, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Warner Chilcott ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072818-001 Jan 9, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-001 Jan 14, 1987 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-002 Jul 10, 1986 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ALBUTEROL SULFATE

Country Patent Number Title Estimated Expiration
Israel 266814 התקן שאיפה עם מודול אלקטרוניקה משולב (Inhalation device with integrated electronics module) ⤷  Sign Up
Australia 2015308748 Compliance monitoring module for a breath-actuated inhaler ⤷  Sign Up
Japan 2022130563 組み込まれた電子モジュールを有する吸入デバイス ⤷  Sign Up
China 105903110 用于吸入器的剂量计数器、吸入器及其轴 (DOSE COUNTERS FOR INHALERS, INHALERS AND METHODS OF the bearings THEREOF) ⤷  Sign Up
>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.