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PROAIR HFA Drug Profile

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Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from eight suppliers. There are five patents protecting this drug.

This drug has sixty-nine patent family members in twenty-one countries.

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

Summary for Tradename: PROAIR HFA

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list8

Pharmacology for Tradename: PROAIR HFA

Clinical Trials for: PROAIR HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes6,446,627<disabled>Y <disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes7,105,152<disabled>Y <disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 2004RXYes7,566,445<disabled>Y <disabled>
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Expired Patents for Tradename: PROAIR HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,695,743<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,766,573<disabled>
Teva Branded Pharm
PROAIR HFA
albuterol sulfate
AEROSOL, METERED;INHALATION021457-001Oct 29, 20045,605,674<disabled>
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Non-Orange Book Patents for Tradename: PROAIR HFA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,743,413 Suspension aerosol formulations<disabled in preview>
7,101,534Suspension aerosol formulations<disabled in preview>
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International Patent Family for Tradename: PROAIR HFA

Country Document Number Estimated Expiration
Germany69729485<disabled in preview>
United Kingdom9616237<disabled in preview>
Denmark0617610<disabled in preview>
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