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Last Updated: July 29, 2021

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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, Adaptis, Amneal Pharms, Anbison Lab, Apotex Inc, Cipla, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Vintage Pharms Llc, Msd Merck Co, Accord Hlthcare, Apotex Corp, Glenmark Generics, L Perrigo Co, and Laboratorios Liomont, and is included in fifty-two 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-three suppliers are listed for this compound.

Drug Sales Revenue Trends for montelukast sodium

See drug sales revenues for montelukast sodium

Recent Clinical Trials for montelukast sodium

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

SponsorPhase
Mansoura University Children HospitalPhase 1
Samarkand State Medical InstitutePhase 4
Merck Sharp & Dohme Corp.Phase 2

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
Teva Pharms MONTELUKAST SODIUM montelukast sodium GRANULE;ORAL 090955-001 Aug 3, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Aurobindo Pharma Ltd MONTELUKAST SODIUM montelukast sodium GRANULE;ORAL 213471-001 Feb 18, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Macleods Pharms Ltd MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 203366-001 Sep 11, 2014 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lannett Co Inc MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 201522-001 Aug 3, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Jubilant Generics MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203795-002 Feb 27, 2015 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Pharms Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 079142-002 Aug 3, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ⤷  Try it Free ⤷  Try it Free
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ⤷  Try it Free ⤷  Try it Free
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ⤷  Try it Free ⤷  Try it Free
>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 19/1999 Austria ⤷  Try it Free 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 SPC/GB98/025 United Kingdom ⤷  Try it Free 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 ⤷  Try it Free 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 9890027-7 Sweden ⤷  Try it Free 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 it Free 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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