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Last Updated: August 5, 2020

DrugPatentWatch Database Preview

Montelukast sodium - Generic Drug Details

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What are the generic drug sources for montelukast sodium and what is the scope of freedom to operate?

Montelukast sodium is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Torrent, Merck, Anbison Lab, Apotex Inc, Cipla, Graviti Pharms, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unichem Labs Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, Msd Merck Co, Accord Hlthcare, Amneal Pharms, Apotex Corp, Glenmark Generics, and L Perrigo Co, and is included in fifty NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Montelukast sodium has twenty-eight patent family members in twenty-five countries.

There are thirty-five drug master file entries for montelukast sodium. Forty-one suppliers are listed for this compound.

Drug Sales Revenue Trends for montelukast sodium

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Recent Clinical Trials for montelukast sodium

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
Beijing Chao Yang HospitalPhase 4
GlaxoSmithKlinePhase 1

See all montelukast sodium clinical trials

Pharmacology for montelukast sodium
Paragraph IV (Patent) Challenges for MONTELUKAST SODIUM
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 montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 202843-001 Sep 10, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 207464-002 Dec 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 208621-002 Jul 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 201581-002 Aug 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Graviti Pharms MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 209012-001 Apr 24, 2017 AB RX No No   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 montelukast sodium

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, CHEWABLE;ORAL 020830-001 Feb 20, 1998   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 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for montelukast sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
McKesson
Mallinckrodt
AstraZeneca
Colorcon

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