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Singulair Drug Profile

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Singulair is a drug marketed by Merck and is included in three NDAs. It is available from ten 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. Fifty-seven 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 list10

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
TABLET;ORAL020829-002Feb 20, 1998RXYes<disabled><disabled>
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Expired Patents for Tradename: SINGULAIR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 20025,565,473*PED<disabled>
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 20005,565,473*PED<disabled>
Merck
SINGULAIR
montelukast sodium
TABLET;ORAL020829-002Feb 20, 19985,565,473*PED<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 Estimated Expiration
EcuadorSP045082<disabled in preview>
Portugal1441701<disabled in preview>
Japan4420671<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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Supplementary Protection Certificates for Tradename: SINGULAIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/1999Austria<disabled>PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
C/GB98/025United Kingdom<disabled>PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
C0022France<disabled>PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
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