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Montelukast sodium - Generic Drug Details

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

This ingredient has twenty-five patent family members in twenty-five countries.

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

Summary for Generic Name: montelukast sodium

Tradenames:2
Patents:1
Applicants:23
NDAs:43
Drug Master File Entries: see list32
Suppliers / Packagers: see list59
Bulk Api Vendors: see list43
Clinical Trials: see list994
Patent Applications: see list1,914
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd
MONTELUKAST SODIUM
montelukast sodium
TABLET;ORAL203432-001Jul 31, 2015RXNo► subscribe► subscribe
Vintage Pharms Llc
MONTELUKAST SODIUM
montelukast sodium
TABLET;ORAL091576-001Aug 3, 2012RXNo► subscribe► subscribe
West-ward Pharms Int
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL091128-002Aug 3, 2012RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 20025,565,473*PED► subscribe
Merck
SINGULAIR
montelukast sodium
TABLET;ORAL020829-002Feb 20, 19985,565,473*PED► subscribe
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 19985,565,473*PED► subscribe
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International Patent Family for Ingredient: montelukast sodium

Country Document Number Estimated Expiration
Canada2463947► subscribe
South Korea101094084► subscribe
Egypt24380► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MONTELUKAST SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90027-7Sweden► subscribePRODUCT 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
C/GB98/025United Kingdom► subscribePRODUCT 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
/1999Austria► subscribePRODUCT 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
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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 verifification 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.

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