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Last Updated: March 22, 2023

PROAIR HFA Drug Patent Profile


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When do Proair Hfa patents expire, and what generic alternatives are available?

Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-two patent family members in twenty-eight countries.

The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Proair Hfa

A generic version of PROAIR HFA was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.

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Drug patent expirations by year for PROAIR HFA
Drug Prices for PROAIR HFA

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Drug Sales Revenue Trends for PROAIR HFA

See drug sales revenues for PROAIR HFA

Recent Clinical Trials for PROAIR HFA

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

SponsorPhase
University of North Carolina, Chapel HillEarly Phase 1
Wake Forest University Health SciencesEarly Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.Early Phase 1

See all PROAIR HFA clinical trials

Paragraph IV (Patent) Challenges for PROAIR HFA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROAIR HFA Inhalation Aerosol albuterol sulfate 0.09 mg base per actuation 021457 1 2012-05-18

US Patents and Regulatory Information for PROAIR HFA

PROAIR HFA is protected by ten US patents.

Patents protecting PROAIR HFA

Dose counter for inhaler having a bore and shaft arrangement
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler and method for counting doses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Suspension aerosol formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Metered-dose inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: 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
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
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
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
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
>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 PROAIR HFA

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 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
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 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

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Serving leading biopharmaceutical companies globally:

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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.