Medication Guide App

Generic Malarone Availability

See also: Generic Malarone Pediatric

Malarone is a brand name of atovaquone/proguanil, approved by the FDA in the following formulation(s):

MALARONE (atovaquone; proguanil hydrochloride - tablet; oral)

Has a generic version of Malarone been approved?

A generic version of Malarone has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Malarone and have been approved by the FDA:

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (atovaquone; proguanil hydrochloride tablet; oral)

  • Manufacturer: GLENMARK GENERICS
    Approval date: January 12, 2011
    Strength(s): 250MG;100MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Malarone. 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.

  • Combination of atovaquone with proguanil for the treatment of protozoal infections
    Patent 5,998,449
    Issued: December 7, 1999
    Inventor(s): Gutteridge; Winston Edward & Hutchinson; David Brian Ashton & Latter; Victoria Susan & Pudney; Mary
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to combinations of atovaquone and proguanil, their use in the treatment and propinylaxis of parasitic infections, such as protozoal parasitic infections, e.g. malaria and toxoplasmosis, and infections caused by P.carinii and their use in the manunfacture of medicaments for the treatment and/or prophylaxis of such infections. The combinations can conveniently be administered in a single pharmaceutical formulation. Preferably, atovaquone and proguanil are administered in a potentiating ratio so that they act in synergy.
    Patent expiration dates:
    • November 25, 2013
      ✓ 
      Patent use: TREATMENT OF PROTOZOAL INFECTION
    • May 25, 2014
      ✓ 
      Pediatric exclusivity
  • Combination of atovaquone with proguanil for the treatment of protozoal infections
    Patent 6,166,046
    Issued: December 26, 2000
    Inventor(s): Gutteridge; Winston Edward & Hutchinson; David Brian Ashton & Latter; Victoria Susan & Pudney; Mary
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to combinations of atovaquone and proguanil, their use in the treatment and prophylaxis of parasitic infections such as protozoal parasitic infections, e.g., malaria and toxoplasmosis, and infections caused by P. carinii and their use in the manufacture of medicaments for the treatment and/or prophylaxis of such infections. The combinations can conveniently be administered in a single pharmaceutical formulation. Preferably, atovaquone and proguanil are administered in a potentiating ratio so that they act in synergy.
    Patent expiration dates:
    • November 25, 2013
      ✓ 
      Patent use: METHOD OF USE OF ATOVAQUONE AND PROGUANIL
    • May 25, 2014
      ✓ 
      Pediatric exclusivity
  • Preventing protozoal infections
    Patent 6,291,488
    Issued: September 18, 2001
    Inventor(s): Gutteridge; Winston Edward & Hutchinson; David Brian Ashton & Latter; Victoria Susan & Pudney; Mary
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to combinations of atovaquone and proguanil, their use in the treatment and prophylaxis of parasitic infections such as protozoal parasitic infections, e.g., malaria and toxoplasmosis, and infections caused by P. carinii and their use in the manufacture of medicaments for the treatment and/or prophylaxis of such infections. The combinations can conveniently be administered in a single pharmaceutical formulation. Preferably, atovaquone and proguanil are administered in a potentiating ratio so that they act in synergy.
    Patent expiration dates:
    • November 25, 2013
      ✓ 
      Patent use: METHOD OF USE OF ATOVAQUONE AND PROGUANIL
    • May 25, 2014
      ✓ 
      Pediatric exclusivity

See also...

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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