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PROVENTIL-HFA Drug Profile

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Proventil-hfa is a drug marketed by 3M and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug.

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

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

Summary for Tradename: PROVENTIL-HFA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Pharmacology for Tradename: PROVENTIL-HFA

Clinical Trials for: PROVENTIL-HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996RXYes5,775,321<disabled>Y <disabled>
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 1996RXYes6,006,745<disabled>Y <disabled>
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Expired Patents for Tradename: PROVENTIL-HFA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19965,225,183<disabled>
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19965,766,573<disabled>
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19965,605,674<disabled>
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Non-Orange Book Patents for Tradename: PROVENTIL-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
6,036,942 Seal configuration for aerosol canister<disabled in preview>
6,030,682 Container for aerosol formulation<disabled in preview>
5,290,539 Device for delivering an aerosol<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PROVENTIL-HFA

Country Document Number Estimated Expiration
South Africa9110143<disabled in preview>
Spain2109696<disabled in preview>
Australia665938<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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