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-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 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 OHM on July 15th, 1986.
Summary for CALDOLOR
| International Patents: | 56 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 197 |
| Clinical Trials: | 23 |
| Patent Applications: | 4,276 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
Injectable ibuprofen formulation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-003 | Jan 25, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | ⤷ Try a Trial | |
| Denmark | 2405748 | ⤷ Try a Trial | |
| Australia | 2013232038 | Injectable ibuprofen formulation | ⤷ Try a Trial |
| South Korea | 20140014350 | ADMINISTRATION OF INTRAVENOUS IBUPROFEN | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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