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Generic Katerzia Availability

Last updated on Nov 7, 2023.

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

KATERZIA (amlodipine benzoate - suspension;oral)

  • Manufacturer: AZURITY
    Approval date: July 8, 2019
    Strength(s): EQ 1MG BASE/ML [RLD]

Has a generic version of Katerzia been approved?

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

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

  • Amlodipine formulations
    Patent 10,695,329
    Issued: June 30, 2020
    Inventor(s): Brauer Scott & Mosher Gerold L.
    Assignee(s): SILVERGATE PHARMACEUTICALS, INC.

    Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

    Patent expiration dates:

    • October 16, 2037
      ✓ 
      Drug product
  • Amlodipine formulations
    Patent 10,799,453
    Issued: October 13, 2020
    Inventor(s): Brauer Scott & Mosher Gerold L.
    Assignee(s): Silvergate Pharmaceuticals, Inc.

    Provided herein are stable amlodipine liquid formulations. Also provided herein are methods of using amlodipine liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

    Patent expiration dates:

    • April 11, 2039
      ✓ 
      Drug product
  • Amlodipine formulations
    Patent 10,894,039
    Issued: January 19, 2021
    Inventor(s): Brauer Scott & Mosher Gerold L.
    Assignee(s): Silvergate Pharmaceuticals, Inc.

    Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION
    • October 6, 2037
      ✓ 
      Patent use: METHOD OF TREATING HYPERTENSION
  • Amlodipine formulations
    Patent 10,952,998
    Issued: March 23, 2021
    Inventor(s): Brauer Scott & Mosher Gerold L.
    Assignee(s): Silvergate Pharmaceuticals, Inc.

    Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Drug product
  • Amlodipine formulations
    Patent 10,959,991
    Issued: March 30, 2021
    Inventor(s): Brauer Scott & Mosher Gerold L.
    Assignee(s): Silvergate Pharmaceuticals, Inc.

    Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Patent use: ANGINA PECTORIS
    • October 6, 2037
      ✓ 
      Patent use: ANGINA
  • Patent 11,364,230
    Issued: November 30, -0001

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Drug product
  • Patent 11,471,409
    Issued: November 30, -0001

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Patent use: A METHOD OF TREATING CORONARY ARTERY DISEASE
    • October 6, 2037
      ✓ 
      Patent use: A METHOD OF TREATING HYPERTENSION
  • Patent 11,484,498
    Issued: November 30, -0001

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      Drug product
  • Patent 11,701,326
    Issued: November 30, -0001

    Patent expiration dates:

    • October 6, 2037
      ✓ 
      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.

Further information

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

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