Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chubb
Express Scripts
Cerilliant
Teva
Queensland Health
Covington
Fish and Richardson
Accenture
Johnson and Johnson
Cantor Fitzgerald

Generated: December 11, 2017

DrugPatentWatch Database Preview

Montelukast sodium - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for montelukast sodium and what is the scope of montelukast sodium freedom to operate?

Montelukast sodium
is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Merck, Anbison Lab Co Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Hetero Labs Ltd V, Jubilant Generics, Kremers Urban Pharms, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Msd Merck Co, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, Perrigo R And D, and Unichem Labs Ltd, and is included in forty-six 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 and five supplementary protection certificates in five countries.

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

Pharmacology for montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Jubilant GenericsMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL203795-001Feb 27, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Unimark Remedies LtdMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL203037-002Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva PharmsMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL078723-001Aug 3, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cspc Ouyi Pharm CoMONTELUKAST SODIUMmontelukast sodiumTABLET;ORAL209012-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL201581-002Aug 6, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL079142-001Aug 3, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdMONTELUKAST SODIUMmontelukast sodiumGRANULE;ORAL203438-001Jul 31, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdMONTELUKAST SODIUMmontelukast sodiumTABLET;ORAL201582-001Aug 6, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sandoz IncMONTELUKAST SODIUMmontelukast sodiumTABLET, CHEWABLE;ORAL091414-001Aug 3, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntMONTELUKAST SODIUMmontelukast sodiumTABLET;ORAL090655-001Aug 3, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
MerckSINGULAIRmontelukast sodiumGRANULE;ORAL021409-001Jul 26, 2002► Subscribe► Subscribe
Msd Merck CoSINGULAIRmontelukast sodiumTABLET;ORAL020829-002Feb 20, 1998► Subscribe► Subscribe
Msd Merck CoSINGULAIRmontelukast sodiumTABLET, CHEWABLE;ORAL020830-001Feb 20, 1998► Subscribe► Subscribe
Msd Merck CoSINGULAIRmontelukast sodiumTABLET, CHEWABLE;ORAL020830-002Mar 3, 2000► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: montelukast sodium

Country Document Number Estimated Expiration
Portugal1441701► Subscribe
EcuadorSP045082► Subscribe
Brazil0213477► Subscribe
Norway20042167► Subscribe
Austria385781► Subscribe
SloveniaEP1441701► Subscribe
Peru06382003► Subscribe
Denmark1441701► Subscribe
Spain2298431► Subscribe
Germany60225040► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: MONTELUKAST SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/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
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
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Baxter
Farmers Insurance
Mallinckrodt
Chinese Patent Office
Healthtrust
Johnson and Johnson
UBS
Merck
US Department of Justice

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot