CALDOLOR Drug Patent Profile
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Which patents cover Caldolor, and when can generic versions of Caldolor launch?
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-nine 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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Questions you can ask:
- What is the 5 year forecast for CALDOLOR?
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Summary for CALDOLOR
International Patents: | 56 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 207 |
Clinical Trials: | 23 |
Patent Applications: | 4,333 |
Drug Prices: | Drug price information for CALDOLOR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CALDOLOR |
What excipients (inactive ingredients) are in CALDOLOR? | CALDOLOR excipients list |
DailyMed Link: | CALDOLOR at DailyMed |
Recent Clinical Trials for CALDOLOR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yonsei University | N/A |
St. Joseph's Hospital and Medical Center, Phoenix | Phase 2 |
St. Joseph's Hospital and Medical Center, Phoenix | Phase 4 |
Pharmacology for CALDOLOR
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for CALDOLOR
CALDOLOR is protected by ten US patents and two FDA Regulatory Exclusivities.
Patents protecting CALDOLOR
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION
Treating 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, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
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, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Administration of 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, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Injectable ibuprofen formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
Injectable ibuprofen formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: 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
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
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 | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Portugal | 2825039 | ⤷ Sign Up | |
Japan | 2013500964 | ⤷ Sign Up | |
South Korea | 101971412 | ⤷ Sign Up | |
South Korea | 20140014350 | ADMINISTRATION OF INTRAVENOUS IBUPROFEN | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2013138628 | ⤷ Sign Up | |
China | 102625656 | Treating critically ill patients with intravenous ibuprofen | ⤷ 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 |