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Arformoterol tartrate - Generic Drug Details

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Arformoterol tartrate is the generic ingredient in one branded drug marketed by Sunovion and is included in one NDA. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for arformoterol tartrate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: arformoterol tartrate

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packaging: see list1
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: arformoterol tartrate

Tentative approvals for ARFORMOTEROL TARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; INHALATION15MCG(BASE)/2ML

Clinical Trials for: arformoterol tartrate

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, 2006RXYes6,720,453<disabled>Y <disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,473,710<disabled> <disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,541,385<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: arformoterol tartrate

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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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Non-Orange Book Patents for Generic Ingredient: arformoterol tartrate

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>
8,623,922Bronchodilating Beta-agonist compositions and methods<disabled in preview>
6,268,533 Formoterol process<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 Ingredient: arformoterol tartrate

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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