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Generic CaroSpir Availability

Last updated on Jan 11, 2023.

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

CAROSPIR (spironolactone - suspension;oral)

  • Manufacturer: CMP DEV LLC
    Approval date: August 4, 2017
    Strength(s): 25MG/5ML [RLD]

Has a generic version of CaroSpir been approved?

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

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

  • Patent 10,493,083

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Patent 10,624,906

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Patent 10,660,907

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Patent 10,888,570

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Patent 11,389,461

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Patent 11,395,828

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Patent use: CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE
    • October 28, 2036
      ✓ 
      Patent use: CAROSPIR IS INDICATED AS AN ADD-ON THERAPY FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER AGENTS
    • October 28, 2036
      ✓ 
      Patent use: CAROSPIR IS INDICATED FOR THE MANAGEMENT OF EDEMA IN ADULT CIRRHOTIC PATIENTS WHEN EDEMA IS NOT RESPONSIVE TO FLUID AND SODIUM RESTRICTION
  • Patent 11,491,166

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Drug product
  • Spironolactone aqueous formulations
    Patent 9,757,394
    Issued: September 12, 2017
    Assignee(s): CMP DEVELOPMENT LLC

    Disclosed herein is a pharmaceutical composition, comprising: (a) spironolactone; (b) a xanthan gum; (c) an anti-foaming agent; (d) a preservative; (f) a dispersing agent; (g) a sweetening agent; (h) a flavoring agent; (i) optionally a buffer to maintain the pH of the pharmaceutical composition within a range described herein; and (j) a sufficient amount of a water vehicle.

    Patent expiration dates:

    • October 28, 2036
      ✓ 
      Patent use: CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE
      ✓ 
      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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