You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Montelukast sodium - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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, Organon, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Generics, Graviti Pharms, and L Perrigo Co, and is included in fifty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for montelukast sodium
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
The Children's Hospital of Zhejiang University School of MedicinePhase 4
Zhejiang Provincial Hospital of TCMPhase 4

See all montelukast sodium clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 201508-001 Aug 3, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 079142-002 Aug 3, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Molecular MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 207464-002 Dec 6, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203795-002 Feb 27, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 205107-002 Sep 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 202717-001 Sep 21, 2012 AB RX No No ⤷  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 montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ⤷  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;ORAL 020829-002 Feb 20, 1998 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.