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Profile for Tradename: Singulair

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Singulair is a drug marketed by Merck and is included in three NDAs. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in twenty-five countries.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for Tradename: Singulair

Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list41

Pharmacology for Tradename: Singulair

Clinical Trials for: Singulair

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes8,007,830<disabled>Y<disabled>
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 1998RXYes<disabled><disabled>
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes<disabled><disabled>
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 2000RXNo<disabled><disabled>
Merck
SINGULAIR
montelukast sodium
TABLET;ORAL020829-002Feb 20, 1998RXYes<disabled><disabled>
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Paragraph IV activity for: SINGULAIR

Drugname Dosage Strength RLD Submissiondate
montelukastTablets10 mgSingulair2/20/2007
montelukast sodiumChewable Tablets4 mg and 5 mgSingulair12/26/2006

International Patent Family for Tradename: SINGULAIR

Country Document Number Publication Date
Norway20042167May 25, 2004
Egypt24380Apr 05, 2009
Malaysia148466Apr 30, 2013
Slovenia1441701Aug 31, 2008
Canada2463947May 01, 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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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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