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Generic Caldolor Availability

Last updated on Sep 6, 2023.

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

CALDOLOR (ibuprofen - solution;intravenous)

  • Manufacturer: CUMBERLAND PHARMS
    Approval date: June 11, 2009
    Strength(s): 400MG/4ML (100MG/ML) (discontinued), 800MG/8ML (100MG/ML) [RLD]
  • Manufacturer: CUMBERLAND PHARMS
    Approval date: January 25, 2019
    Strength(s): 800MG/200ML (4MG/ML) [RLD]

Has a generic version of Caldolor been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Caldolor. 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 8,735,452

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
  • Patent 8,871,810

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
  • Patent 9,012,508

    Patent expiration dates:

    • September 14, 2030
      ✓ 
      Patent use: MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
  • Patent 9,072,661

    Patent expiration dates:

    • March 16, 2032
      ✓ 
      Patent use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
  • Patent 9,072,710

    Patent expiration dates:

    • March 16, 2032
      ✓ 
      Patent use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
  • Patent 9,114,068

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL
  • Patent 9,138,404

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
  • Patent 9,295,639

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
  • Patent 9,649,284

    Patent expiration dates:

    • September 30, 2029
      ✓ 
      Patent use: MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF

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:

    • November 19, 2024 - CLINICAL TRIAL STUDY RESULTS

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.

Medical Disclaimer