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Generic Canasa Availability

Last updated on Nov 7, 2023.

Canasa is a brand name of mesalamine, approved by the FDA in the following formulation(s):

CANASA (mesalamine - suppository;rectal)

  • Manufacturer: ABBVIE
    Approval date: January 5, 2001
    Strength(s): 500MG (discontinued)
  • Manufacturer: ABBVIE
    Approval date: November 5, 2004
    Strength(s): 1GM [RLD] [AB]

Has a generic version of Canasa been approved?

A generic version of Canasa 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 Canasa and have been approved by the FDA:

mesalamine suppository;rectal

  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: August 14, 2020
    Strength(s): 1GM [AB]
  • Manufacturer: AMRING PHARMS
    Approval date: June 21, 2019
    Strength(s): 1GM [AB]
  • Manufacturer: ANNORA PHARMA
    Approval date: March 19, 2020
    Strength(s): 1GM [AB]
  • Manufacturer: MYLAN
    Approval date: November 24, 2015
    Strength(s): 1GM [AB]
  • Manufacturer: PHARM SOURCING
    Approval date: April 19, 2019
    Strength(s): 1GM [AB]
  • Manufacturer: SANDOZ
    Approval date: June 12, 2019
    Strength(s): 1GM [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: February 12, 2020
    Strength(s): 1GM [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Canasa. 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: Generic Drug FAQ.

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.

  • Mesalamine suppository
    Patent 8,217,083
    Issued: July 10, 2012
    Inventor(s): Gauthier Carl & Dumoulin Yves & Powell David
    Assignee(s): Aptalis Pharma Canada Inc.

    The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 400 to about 600 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 870 to about 1715 mg. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP <616>) and a hard fat having an ascending melting point of 32 to 35.5° C. Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40° C. and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.

    Patent expiration dates:

    • June 6, 2028
      ✓ 
      Drug product
  • Mesalamine suppository
    Patent 8,436,051
    Issued: May 7, 2013
    Inventor(s): Gauthier Carl & Dumoulin Yves & Powell David & Moreau Hugues
    Assignee(s): Aptalis Pharma Canada Inc.

    The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP <616>) and a hard fat having an ascending melting point of 32 to 35.5° C. Yet another embodiment is a mesalamine rectal suppository comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have a surface area of from about 0.1 m/g to about 2.8 m/g (e.g., from about 0.1 m/g to about 1.3 m/g). Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40° C. and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.

    Patent expiration dates:

    • June 6, 2028
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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