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Serving leading biopharmaceutical companies globally:

AstraZeneca
Federal Trade Commission
Dow
UBS
Johnson and Johnson
Daiichi Sankyo
Moodys
Cerilliant
Baxter
Julphar

Generated: January 17, 2018

DrugPatentWatch Database Preview

SINGULAIR Drug Profile

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When do Singulair patents expire, and what generic alternatives are available?

Singulair is a drug marketed by Merck and Msd Merck Co and is included in three NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-three drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for SINGULAIR
Drug patent expirations by year for SINGULAIR
Pharmacology for SINGULAIR

US Patents and Regulatory Information for SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ➤ Subscribe ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ➤ Subscribe ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ➤ Subscribe ➤ Subscribe
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SINGULAIR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 10 mg ➤ Subscribe 2/20/2007
➤ Subscribe Chewable Tablets 4 mg and 5 mg ➤ Subscribe 12/26/2006

International Patents for SINGULAIR

Supplementary Protection Certificates for SINGULAIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90009 Netherlands ➤ Subscribe PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
C0022 France ➤ Subscribe PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C/GB98/025 United Kingdom ➤ Subscribe 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
/1999 Austria ➤ Subscribe 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
90027-7 Sweden ➤ Subscribe PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Citi
Chinese Patent Office
AstraZeneca
Boehringer Ingelheim
US Army
Fish and Richardson
Novartis

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