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Details for Generic Name: arformoterol tartrate

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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-two patent family members in thirteen countries.

There are three drug master file entries for arformoterol tartrate. One supplier is listed 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 list4
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: arformoterol tartrate

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, 2006RXYes7,473,710<disabled><disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,472,563<disabled>Y<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,667,344<disabled>Y<disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes6,814,953<disabled><disabled>
Sunovion
BROVANA
arformoterol tartrate
SOLUTION;INHALATION021912-001Oct 6, 2006RXYes7,462,645<disabled><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
6,268,533 Formoterol process<disabled in preview>
8,114,912Bronchodilating .beta.-agonist compositions and methods<disabled in preview>
7,342,132Formoterol tartrate process and polymorph<disabled in preview>
7,964,753Formoterol tartrate process and polymorph<disabled in preview>
7,732,641Formoterol tartrate process and polymorph<disabled in preview>
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International Patent Family for Ingredient: arformoterol tartrate

Country Document Number Publication Date
Portugal1446380Jan 07, 2010
Japan2009046490Mar 05, 2009
Canada2271004May 22, 1998
Denmark0938467Oct 07, 2002
World Intellectual Property Organization (WIPO)02083079Feb 13, 2003
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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.

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Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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