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Serving leading biopharmaceutical companies globally:

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Cipla
Baxter
Dow
Teva
Accenture
Farmers Insurance
Healthtrust

Generated: February 25, 2018

DrugPatentWatch Database Preview

Montelukast sodium - Generic Drug Details

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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.

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

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 201508-002 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Anbison Lab Co Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 205695-001 Nov 5, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Macleods Pharms Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 203582-001 Mar 12, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hetero Labs Ltd V MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 204093-001 May 22, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Torrent Pharms Ltd MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 090984-002 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Kremers Urban Pharms MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 200405-002 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 079142-002 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms Llc MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 091576-001 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms Llc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 091588-001 Aug 3, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int MONTELUKAST SODIUM montelukast sodium TABLET;ORAL 090655-001 Aug 3, 2012 AB RX 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

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Expired US Patents for montelukast sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for montelukast sodium

Supplementary Protection Certificates for montelukast sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90027-7 Sweden ➤ Sign Up PRODUCT 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
C0022 France ➤ Sign Up PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C/GB98/025 United Kingdom ➤ Sign Up PRODUCT 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
/1999 Austria ➤ Sign Up PRODUCT 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
90009 Netherlands ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Cerilliant
Johnson and Johnson
QuintilesIMS
Dow
Covington
AstraZeneca
Harvard Business School

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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