MONTELUKAST SODIUM Drug Patent Profile
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Which patents cover Montelukast Sodium, and what generic alternatives are available?
Montelukast Sodium is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Norvium Bioscience, Teva Pharms, Torrent, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Natco Pharma, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, and L Perrigo Co. and is included in forty-nine NDAs.
The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Montelukast Sodium
A generic version of MONTELUKAST SODIUM was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3rd, 2012.
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Questions you can ask:
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Summary for MONTELUKAST SODIUM
| US Patents: | 0 |
| Applicants: | 28 |
| NDAs: | 49 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 81 |
| Patent Applications: | 3,980 |
| Drug Sales Revenues: | Drug sales revenues for MONTELUKAST SODIUM |
| DailyMed Link: | MONTELUKAST SODIUM at DailyMed |
Recent Clinical Trials for MONTELUKAST SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mansoura University Children Hospital | Phase 1 |
| Zhejiang Provincial Hospital of TCM | Phase 4 |
| First People's Hospital Affiliated to Huzhou University | Phase 4 |
Pharmacology for MONTELUKAST SODIUM
| Drug Class | Leukotriene Receptor Antagonist |
| Mechanism of Action | Leukotriene Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent Pharms Ltd | MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 090984-001 | Aug 3, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Natco Pharma | MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 079142-002 | Aug 3, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 204604-001 | Sep 4, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| L Perrigo Co | MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 206112-001 | Apr 26, 2017 | DISCN | No | No | ⤷ 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 |
