Generic Maxalt-MLT Availability

See also: Generic Maxalt

Maxalt-MLT is a brand name of rizatriptan, approved by the FDA in the following formulation(s):

MAXALT-MLT (rizatriptan benzoate - tablet, orally disintegrating;oral)

  • Manufacturer: MERCK
    Approval date: June 29, 1998
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [RLD] [AB]

Has a generic version of Maxalt-MLT been approved?

A generic version of Maxalt-MLT 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 Maxalt-MLT and have been approved by the FDA:

rizatriptan benzoate tablet, orally disintegrating;oral

  • Manufacturer: APOTEX INC
    Approval date: July 1, 2013
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 1, 2013
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: July 1, 2013
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: December 31, 2012
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: NATCO PHARMA LTD
    Approval date: July 1, 2013
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: July 1, 2013
    Strength(s): EQ 5MG BASE [AB], EQ 10MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Maxalt-MLT. 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.

  • Method of identifying freeze-dried dosage forms
    Patent 5,457,895
    Issued: October 17, 1995
    Inventor(s): Thompson; Andrew R. & Yarwood; Richard J. & Kearney; Patrick
    Assignee(s): R. P. Scherer Corporation
    The invention permits the application of an identifying mark onto a freeze-dried tablet without the need for application of pressure or for printing directly on the tablet. The invention comprises the preparation of a freeze-dried unit that is embossed with an identifying mark such as a manufacturer's logo, medicinal component strength, or other information relating to the unit. The desired identifying mark is first embossed onto the base of a container such as a blister pocket. Liquid suspension is then filled into the container and freeze-dried therein. The resulting freeze-dried unit in the container is thereby embossed with substantial copy of the identifying mark that was embossed on the base of the container. The embossed identifying mark on the base of the container remains thereon as well, providing at reduced manufacturing cost the added ability to learn the identifying mark on the enclosed freeze-dried unit without opening the blister pack.
    Patent expiration dates:
    • October 1, 2013
      ✓ 
      Drug product
    • April 1, 2014
      ✓ 
      Pediatric exclusivity

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:
    • December 16, 2014 -
    • June 16, 2015 -

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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