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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
McKinsey
Moodys
McKesson

Last Updated: May 28, 2022

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 nine patents protecting this drug.

This drug has fifty-five 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 nine suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Drug patent expirations by year for CALDOLOR
Drug Prices for CALDOLOR

See drug prices for CALDOLOR

US Patents and Regulatory Information for CALDOLOR

CALDOLOR is protected by nine US patents and one FDA Regulatory Exclusivity.

Patents protecting CALDOLOR

Treating patients with intravenous ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

Injectable ibuprofen formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

Treating patients with intravenous ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CALDOLOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-001 Jun 11, 2009 See Plans and Pricing See Plans and Pricing
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CALDOLOR

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

Country Patent Number Title Estimated Expiration
Japan 2012523377 See Plans and Pricing
China 102791268 Treating critically ill patients with intravenous ibuprofen See Plans and Pricing
South Korea 20170091775 정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Boehringer Ingelheim
Mallinckrodt
Moodys
Baxter

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.