DrugPatentWatch Database Preview
CALDOLOR Drug Profile
» See Plans and Pricing
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-three patent family members in fourteen countries.
The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and eight suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
US ANDA 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: | 53 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 170 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,091 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CALDOLOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CALDOLOR |
| 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 4 |
| Seoul National University Hospital | N/A |
Pharmacology for CALDOLOR
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for CALDOLOR
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-003 | Jan 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-003 | Jan 25, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CALDOLOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101864559 | Start Trial |
| European Patent Office | 2515906 | Start Trial |
| European Patent Office | 2458988 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013138628 | Start Trial |
| Denmark | 2405748 | Start Trial |
| Canada | 2754922 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
