Generic Coartem Availability

Coartem is a brand name of artemether/lumefantrine, approved by the FDA in the following formulation(s):

COARTEM (artemether; lumefantrine - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: April 7, 2009
    Strength(s): 20MG;120MG [RLD]

Has a generic version of Coartem been approved?

No. There is currently no therapeutically equivalent version of Coartem available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Coartem. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Antimalarial compositions
    Patent 5,677,331
    Issued: October 14, 1997
    Inventor(s): Zhou; Yiqing & Ning; Dianxi & Wang; Shufen & Ding; Deben & Li; Guofu & Shan; Chengqi & Liu; Guangyu
    Assignee(s): Ciba-Geigy AG Institute of Microbiology and Epidemiology, Academy of Military Medical
    The invention relates to a synergistic antimalarial composition which comprises the antimalarial agent benflumetol and also an antimalarial agent from the artemisinine group such as artemether. The composition can be formulated into solid dosage forms such as tablets and is useful for the treatment of drug resistant malaria.
    Patent expiration dates:
    • October 14, 2014
      ✓ 
      Patent use: TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM IN PATIENTS OF 5KG BODYWEIGHT AND ABOVE
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • April 7, 2014 -
    • April 7, 2016 -

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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