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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.

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

Suppliers: see list11

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
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes8,007,830<disabled>Y<disabled>
montelukast sodium
TABLET;ORAL020829-002Feb 20, 1998RXYes<disabled><disabled>
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002RXYes<disabled><disabled>
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 1998RXYes<disabled><disabled>
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 2000RXNo<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
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Preferred citation:

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

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