Generic Caldolor Availability

Last updated on Nov 6, 2024.

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.

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 11,806,400
Patent expiration dates:
- March 16, 2032
  ✓
  Patent use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION
Treating patients with intravenous ibuprofen
Patent 8,735,452
Issued: May 27, 2014
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals Inc.
Methods of treating a patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen in an amount effective to treat at least one condition in the patient chosen from pain, inflammation, and fever and to provide a clinically relevant effect on mean arterial pressure of the patients during the dosage interval comprising no increase or no statistically significant increase in mean arterial pressure.
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
Treating critically ill patients with intravenous ibuprofen
Patent 8,871,810
Issued: October 28, 2014
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals Inc.
Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.
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
Administration of intravenous ibuprofen
Patent 9,012,508
Issued: April 21, 2015
Inventor(s): Pavliv Leo
Assignee(s): Cumberland Pharmaceuticals
An effective dose of intravenous ibuprofen administered every 6 hours in surgery patients is a safe and effective way to reduce both pain and the need for morphine. In preferred embodiments, the administration of intravenous ibuprofen starts with the onset of anesthesia.
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
Injectable ibuprofen formulation
Patent 9,072,661
Issued: July 7, 2015
Inventor(s): Pavliv Leo & Vila Andrew
Assignee(s): Cumberland Pharmaceuticals Inc.
The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.
Patent expiration dates:
- March 16, 2032
  ✓
  Patent use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
Injectable ibuprofen formulation
Patent 9,072,710
Issued: July 7, 2015
Inventor(s): Pavliv Leo & Vila Andrew
Assignee(s): Cumberland Pharmaceuticals Inc.
The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.
Patent expiration dates:
- March 16, 2032
  ✓
  Patent use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
Treating patients with intravenous ibuprofen
Patent 9,114,068
Issued: August 25, 2015
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals, Inc.
Methods of treating a patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen in an amount effective to treat at least one condition in the patient chosen from pain, inflammation, and fever and to provide a clinically relevant effect on mean arterial pressure of the patients during the dosage interval comprising no increase or no statistically significant increase in mean arterial pressure.
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
Treating critically ill patients with intravenous ibuprofen
Patent 9,138,404
Issued: September 22, 2015
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals Inc.
Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.
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
Treating critically ill patients with intravenous ibuprofen
Patent 9,295,639
Issued: March 29, 2016
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals Inc.
Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.
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
Treating critically ill patients with intravenous ibuprofen
Patent 9,649,284
Issued: May 16, 2017
Inventor(s): Pavliv Leo & Rock Amy Dix
Assignee(s): Cumberland Pharmaceuticals, Inc.
Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.
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
- May 11, 2026 - NEW PATIENT POPULATION

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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

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Drug Status

Availability Rx and/or OTC Rx
OTC

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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