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Last Updated: November 22, 2024

COARTEM Drug Patent Profile


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When do Coartem patents expire, and what generic alternatives are available?

Coartem is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in COARTEM is artemether; lumefantrine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artemether; lumefantrine profile page.

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Summary for COARTEM
Drug patent expirations by year for COARTEM
Drug Prices for COARTEM

See drug prices for COARTEM

Recent Clinical Trials for COARTEM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 3
MMV, EDCTP, WANECAMPhase 3
Global FundPhase 4

See all COARTEM clinical trials

Pharmacology for COARTEM
Drug ClassAntimalarial

US Patents and Regulatory Information for COARTEM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis COARTEM artemether; lumefantrine TABLET;ORAL 022268-001 Apr 7, 2009 RX Yes Yes ⤷  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

International Patents for COARTEM

See the table below for patents covering COARTEM around the world.

Country Patent Number Title Estimated Expiration
Germany 10199038 ⤷  Sign Up
Portugal 97945 PROCESSO PARA A PREPARACAO DE COMPOSICOES ANTIMALARIANAS CONTENDO BENFLUMETOL EDERIVADOS ARTEMETER ⤷  Sign Up
Israel 98463 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COARTEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0500823 C300048 Netherlands ⤷  Sign Up PRODUCT NAME: ARTEMETHERUM EN LUMEFANTRINUM, DESGEWENST IN DE VORM VAN EEN FA RMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ARTEMETHERUM EN LUMEFANTRINUM; NATL. REGISTRATION NO/DATE: RVG 25773 20010123; FIRST REGISTRATION: CH 54594 19990122
0500823 2001C/043 Belgium ⤷  Sign Up PRODUCT NAME: ARTEMETHER, LUMEFANTRINE; NAT. REGISTRATION NO/DATE: 206 IS 300 F 3 20010514; FIRST REGISTRATION: CH 54594 19990122
0500823 SPC/GB00/013 United Kingdom ⤷  Sign Up PRODUCT NAME: ARTEMETHER AND LUMEFANTRIN; REGISTERED: CH (IKS) 54594 01 19990122; UK PL 00101/0566 19991130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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