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Last Updated: July 19, 2024

CALDOLOR Drug Patent Profile


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Which patents cover Caldolor, and what generic alternatives are available?

Caldolor is a drug marketed by Cumberland Pharms and is included in one NDA. There are ten patents protecting this drug.

This drug has fifty-six patent family members in fifteen countries.

The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Caldolor

A generic version of CALDOLOR was approved as ibuprofen by STRIDES PHARMA on September 24th, 1986.

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Drug patent expirations by year for CALDOLOR
Drug Prices for CALDOLOR

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Recent Clinical Trials for CALDOLOR

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SponsorPhase
Yonsei UniversityN/A
St. Joseph's Hospital and Medical Center, PhoenixPhase 2
St. Joseph's Hospital and Medical Center, PhoenixPhase 4

See all CALDOLOR clinical trials

Pharmacology for CALDOLOR

US Patents and Regulatory Information for CALDOLOR

CALDOLOR is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting CALDOLOR


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Patented Use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION

Treating patients with intravenous ibuprofen
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Patented 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
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Patented 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
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Patented 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
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Patented Use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

Injectable ibuprofen formulation
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Patented Use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

Treating patients with intravenous ibuprofen
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Patented 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
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Patented 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
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Patented 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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented 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

FDA Regulatory Exclusivity protecting CALDOLOR

CLINICAL TRIAL STUDY RESULTS
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NEW PATIENT POPULATION
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-001 Jun 11, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CALDOLOR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CALDOLOR

See the table below for patents covering CALDOLOR around the world.

Country Patent Number Title Estimated Expiration
South Korea 101777587 ⤷  Sign Up
Canada 2754922 ADMINISTRATION D'IBUPROFENE PAR VOIE INTRAVEINEUSE (ADMINISTRATION OF INTRAVENOUS IBUPROFEN) ⤷  Sign Up
Spain 2823249 ⤷  Sign Up
Japan 5837877 ⤷  Sign Up
Japan 2013500964 ⤷  Sign Up
South Korea 20120089444 TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN ⤷  Sign Up
Japan 2012523377 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALDOLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781277 PA2024501 Lithuania ⤷  Sign Up PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.