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BROVANA Drug Profile

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Brovana is a drug marketed by Sunovion and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in thirteen countries.

The generic ingredient in BROVANA is arformoterol tartrate. There are three drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the arformoterol tartrate profile page.

Summary for Tradename: BROVANA

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: BROVANA

Clinical Trials for: BROVANA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,814,953<disabled> <disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,040,344<disabled>Y <disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,473,710<disabled> <disabled>
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Expired Patents for Tradename: BROVANA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20066,068,833<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20065,795,564<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 20066,866,839<disabled>
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Paragraph IV activity for: BROVANA

Drugname Dosage Strength RLD Submissiondate
arformoterol tartrateInhalation SolutionEq. 0.015 mg base/2 mLBrovana10/1/2009

Non-Orange Book Patents for Tradename: BROVANA

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
7,732,641Formoterol tartrate process and polymorph<disabled in preview>
6,268,533 Formoterol process<disabled in preview>
8,623,922Bronchodilating Beta-agonist compositions and methods<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: BROVANA

Country Document Number Estimated Expiration
Australia2002349914<disabled in preview>
European Patent Office0938467<disabled in preview>
Japan2001503772<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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