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Last Updated: June 28, 2022

ALBUTEROL SULFATE Drug Patent Profile


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Which patents cover Albuterol Sulfate, and when can generic versions of Albuterol Sulfate launch?

Albuterol Sulfate is a drug marketed by Cipla, Lupin, Padagis Us, Sandoz Inc, 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, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Rising, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Mylan, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Fosun Pharma, and Watson Labs Teva. and is included in eighty NDAs.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Drug patent expirations by year 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
Aurobindo Pharma LtdPhase 3
Teva Branded Pharmaceutical Products R&D, Inc.Early Phase 1
University of North Carolina, Chapel HillEarly Phase 1

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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 ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072779-001 Jun 25, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mova ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074302-001 Sep 30, 1994 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077772-002 Sep 25, 2007 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 072765-001 Aug 28, 1991 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Co ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 208804-001 May 21, 2018 AB RX 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
Rising ALBUTEROL SULFATE albuterol sulfate TABLET, EXTENDED RELEASE;ORAL 078092-002 Jan 29, 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

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