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Last Updated: November 4, 2024

SINGULAIR Drug Patent Profile


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

Singulair is a drug marketed by Organon and is included in three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Singulair

A generic version of SINGULAIR was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3rd, 2012.

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Summary for SINGULAIR
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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Michael E. DeBakey VA Medical CenterPhase 1
Baylor College of MedicinePhase 1
Texas A&M UniversityPhase 1

See all SINGULAIR clinical trials

Pharmacology for SINGULAIR
Paragraph IV (Patent) Challenges for SINGULAIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SINGULAIR Oral Granules montelukast sodium 4 mg 021409 1 2008-10-17
SINGULAIR Tablets montelukast sodium 10 mg 020829 2 2007-02-20
SINGULAIR Chewable Tablets montelukast sodium 4 mg and 5 mg 020830 1 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
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ⤷  Sign Up ⤷  Sign Up
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ⤷  Sign Up ⤷  Sign Up
>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 C990009 Netherlands ⤷  Sign Up 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 98C0025 Belgium ⤷  Sign Up PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0480717 98C0022 France ⤷  Sign Up PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717 9890027-7 Sweden ⤷  Sign Up 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 SPC/GB98/025 United Kingdom ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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