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Last Updated: October 2, 2023

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-three 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 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

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

SponsorPhase
Assaf-Harofeh Medical CenterPhase 4
The Whittington Hospital NHS TrustPhase 2/Phase 3
Guy's and St Thomas' NHS Foundation TrustPhase 2/Phase 3

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Organon SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SINGULAIR

See the table below for patents covering SINGULAIR around the world.

Country Patent Number Title Estimated Expiration
Denmark 1441701 ⤷  Try a Trial
Mexico 9101551 ACIDOS DE HIDROXIALQUILQUINOLINA INSATURADOS COMO ANTAGONISTAS DE LEUCOTRIENO ⤷  Try a Trial
Norway 914004 ⤷  Try a Trial
Germany 19875039 ⤷  Try a Trial
Croatia P930751 UNSATURATED HYDROXYALKYLQUINOLINE ACIDS AS LEUKOTRIENE ANTAGONISTS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SINGULAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 SPC/GB98/025 United Kingdom ⤷  Try a 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 19/1999 Austria ⤷  Try a 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
0480717 9890027-7 Sweden ⤷  Try a 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 98C0022 France ⤷  Try a 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 C990009 Netherlands ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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