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Last Updated: July 10, 2020

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SINGULAIR Drug Profile


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Which patents cover Singulair, and when can generic versions of Singulair launch?

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-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Singulair

A generic version of SINGULAIR was approved as montelukast sodium by TEVA PHARMS on August 3rd, 2012.

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Drug patent expirations by year for SINGULAIR
Drug Prices for SINGULAIR

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Drug Sales Revenue Trends for SINGULAIR

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Recent Clinical Trials for SINGULAIR

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SponsorPhase
University College London HospitalsPhase 2/Phase 3
North Middlesex University HospitalPhase 2/Phase 3
Great Ormond Street Hospital for Children NHS Foundation TrustPhase 2/Phase 3

See all SINGULAIR clinical trials

Pharmacology for SINGULAIR
Paragraph IV (Patent) Challenges for SINGULAIR
Tradename Dosage Ingredient NDA Submissiondate
SINGULAIR GRANULE;ORAL montelukast sodium 021409 2008-10-17
SINGULAIR TABLET;ORAL montelukast sodium 020829 2007-02-20
SINGULAIR TABLET, CHEWABLE;ORAL montelukast sodium 020830 2006-12-26

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

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   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SINGULAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717 98C0025 Belgium   Start Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0480717 SPC/GB98/025 United Kingdom   Start Trial 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
0480717 9890027-7 Sweden   Start Trial 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
0480717 C990009 Netherlands   Start Trial 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
0480717 19/1999 Austria   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Harvard Business School
Baxter
Dow
Medtronic

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