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Montelukast sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for montelukast sodium?

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-eight suppliers are listed for this compound.

Summary for Generic Name: montelukast sodium

Tradenames:2
Patents:2
Applicants:23
NDAs:43
Drug Master File Entries: see list32
Suppliers / Packagers: see list58
Bulk Api Vendors: see list43
Clinical Trials: see list998
Patent Applications: see list1,914
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:montelukast sodium at DailyMed

Pharmacology for Ingredient: montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
MONTELUKAST SODIUM
montelukast sodium
TABLET;ORAL202468-001Aug 3, 2012RXNoNo► Subscribe► Subscribe
Jubilant Generics
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL203795-001Feb 27, 2015RXNoNo► Subscribe► Subscribe
Apotex Inc
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL201508-001Aug 3, 2012RXNoNo► Subscribe► Subscribe
Hetero Labs Ltd V
MONTELUKAST SODIUM
montelukast sodium
TABLET;ORAL202843-001Sep 10, 2014RXNoNo► Subscribe► Subscribe
Hetero Labs Ltd V
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL204093-001May 22, 2015RXNoNo► 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, CHEWABLE;ORAL020830-002Mar 3, 20005,565,473*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
Japan4420671► Subscribe
Slovenia1441701► Subscribe
Portugal1441701► Subscribe
Norway20042167► Subscribe
Hungary0401670► 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
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
90009Netherlands► SubscribePRODUCT 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
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
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
/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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