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Last Updated: May 22, 2024

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 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, 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 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-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for albuterol sulfate

See drug prices for albuterol sulfate

Drug Sales Revenue Trends for albuterol sulfate

See drug sales revenues for albuterol sulfate

Recent Clinical Trials for albuterol sulfate

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

SponsorPhase
ParexelPhase 3
Bond Avillion 2 Development LPPhase 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
Apotex Inc ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 078623-002 Apr 5, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Copley Pharm ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072967-001 Nov 22, 1991 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072779-001 Jun 25, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072620-001 Dec 5, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Chartwell Rx ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072151-002 Dec 5, 1989 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
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-001 Jan 14, 1987 ⤷  Sign Up ⤷  Sign Up
Schering PROVENTIL albuterol sulfate SOLUTION;INHALATION 019243-002 Jan 14, 1987 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline VENTOLIN ROTACAPS albuterol sulfate CAPSULE;INHALATION 019489-001 May 4, 1988 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 ⤷  Sign Up ⤷  Sign Up
Muro VOLMAX albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 019604-001 Dec 23, 1992 ⤷  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
Canada 2958894 MODULE DE SURVEILLANCE DE LA CONFORMITE POUR UN INHALATEUR ACTIONNE PAR LA RESPIRATION (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER) ⤷  Sign Up
Eurasian Patent Organization 032332 СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР, СОДЕРЖАЩИЙ СЧЕТЧИК ДОЗ (DOSE COUNTER FOR AN INHALER AND INHALER COMPRISING A DOSE COUNTER) ⤷  Sign Up
Hong Kong 1222812 用於吸入器的劑量計數器、吸入器及其軸 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) ⤷  Sign Up
Israel 223116 מוני מינון למשאפים, משאפים ועמודים למשאפים (Dose counters for inhalers, inhalers and shafts thereof) ⤷  Sign Up
Israel 223118 משאף של תרופה ושיטה להרכבתו (Medicament inhaler and method for its assembly) ⤷  Sign Up
Japan 2014128709 DOSE COUNTER FOR INHALER, INHALER, AND SHAFT OF THE INHALER ⤷  Sign Up
Portugal 2514467 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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