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PROAIR HFA Drug Profile
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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-two 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 list | 8 |
| Drug Prices: : | see details |
Pharmacology for Tradename: PROAIR HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
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;INHALATION | 021457-001 | Oct 29, 2004 | RX | Yes | 6,446,627 | Dec 18, 2017 | Y | |||||||||||||||||||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | RX | Yes | 7,105,152 | Sep 12, 2023 | Y | |||||||||||||||||||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | RX | Yes | 7,566,445 | Jun 4, 2017 | Y | |||||||||||||||||||
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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;INHALATION | 021457-001 | Oct 29, 2004 | 5,605,674 | <disabled> | ||||||||||||||||||||||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | 5,766,573 | <disabled> | ||||||||||||||||||||||
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | 5,695,743 | <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> | |||||||||||||||||||||||||||
| 7,101,534 | Suspension aerosol formulations | <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: PROAIR HFA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2320129 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2008119552 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2011173910 | <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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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 verifification 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.
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