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Generic Apriso Availability

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

APRISO (mesalamine - capsule, extended release;oral)

  • Manufacturer: VALEANT PHARMS INTL
    Approval date: October 31, 2008
    Strength(s): 375MG [RLD]

Has a generic version of Apriso been approved?

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

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

  • Pellet formulation for the treatment of the intestinal tract
    Patent 6,551,620
    Issued: April 22, 2003
    Inventor(s): Norbert; Otterbeck
    Assignee(s): Dr. Falk Pharma GmbH
    An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
      ✓ 
      Patent use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
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      Drug product
  • Pellet formulation for the treatment of the intestinal tract
    Patent 8,337,886
    Issued: December 25, 2012
    Inventor(s): Otterbeck; Norbert
    Assignee(s): Dr. Falk Pharma GmbH
    An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
      ✓ 
      Patent use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
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      Drug product
  • Pellet formulation for the treatment of the intenstinal tract
    Patent 8,496,965
    Issued: July 30, 2013
    Assignee(s): Dr. Falk Pharma GmbH
    An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
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      Drug product
  • Compositions and methods for treatment of bowel diseases with granulated mesalamine
    Patent 8,865,688
    Issued: October 21, 2014
    Assignee(s): Dr. Falk Pharma GmbH
    Disclosed are methods for treating gastrointestinal disorders, e.g., Crohn's disease, ulcerative colitis, and diverticular disease, with a granulated mesalamine formulation. Some formulations use granulated mesalamine in capsule form. Also included are methods to extend remission of ulcerative colitis by administration of a once-daily dosage of granulated mesalamine.
    Patent expiration dates:
    • May 1, 2030
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      Patent use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
  • Pellet formulation for the treatment of the intestinal tract
    Patent 8,911,778
    Issued: December 16, 2014
    Assignee(s): Dr. Falk Pharma GmbH
    An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
      ✓ 
      Patent use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
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      Drug product
  • Pellet formulation for the treatment of the intestinal tract
    Patent 8,940,328
    Issued: January 27, 2015
    Assignee(s): Dr. Falk Pharma GmbH
    An orally administrable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
      ✓ 
      Drug product
  • Pellet formulation for the treatment of the intestinal tract
    Patent 8,956,647
    Issued: February 17, 2015
    Assignee(s): Dr. Falk Pharma GmbH
    An orally administrable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
    Patent expiration dates:
    • April 20, 2018
      ✓ 
      Drug product

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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