Caldolor is a drug owned by Cumberland Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2013 to 2023. Out of these, 10 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 16, 2032. Details of Caldolor's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9072710 | Injectable ibuprofen formulation |
Mar, 2032
(6 years from now) | Active |
| US9072661 | Injectable ibuprofen formulation |
Mar, 2032
(6 years from now) | Active |
| US11806400 | Injectable ibuprofen formulation |
Mar, 2032
(6 years from now) | Active |
| US9012508 | Administration of intravenous ibuprofen |
Sep, 2030
(5 years from now) | Active |
| US8735452 | Treating patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US9114068 | Treating patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US9138404 | Treating critically ill patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US9295639 | Treating critically ill patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US8871810 | Treating critically ill patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US9649284 | Treating critically ill patients with intravenous ibuprofen |
Sep, 2029
(4 years from now) | Active |
| US6727286 | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid |
Nov, 2021
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Caldolor's patents.
Latest Legal Activities on Caldolor's Patents
Given below is the list of recent legal activities going on the following patents of Caldolor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 07 Nov, 2023 | US11806400 |
| Mail Patent eGrant Notification | 07 Nov, 2023 | US11806400 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Nov, 2023 | US11806400 |
| Recordation of Patent Grant Mailed Critical | 07 Nov, 2023 | US11806400 |
| Patent eGrant Notification | 07 Nov, 2023 | US11806400 |
| Recordation of Patent eGrant | 07 Nov, 2023 | US11806400 |
| Email Notification Critical | 19 Oct, 2023 | US11806400 |
| Issue Notification Mailed Critical | 18 Oct, 2023 | US11806400 |
| Dispatch to FDC | 06 Oct, 2023 | US11806400 |
| Application Is Considered Ready for Issue Critical | 06 Oct, 2023 | US11806400 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Caldolor and ongoing litigations to help you estimate the early arrival of Caldolor generic.
Caldolor's Litigations
Caldolor been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 04, 2012, against patent number US9295639. The petitioner , challenged the validity of this patent, with Leo PAVLIV et al as the respondent. Click below to track the latest information on how companies are challenging Caldolor's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9295639 | December, 2012 |
Decision
(17 Sep, 2015) | Leo PAVLIV et al | |
FDA has granted some exclusivities to Caldolor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Caldolor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Caldolor.
Exclusivity Information
Caldolor holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Caldolor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 11, 2012 |
| New Dosing Schedule(D-152) | Nov 20, 2018 |
| M(M-128) | Nov 19, 2024 |
| New Patient Population(NPP) | May 11, 2026 |
US patents provide insights into the exclusivity only within the United States, but Caldolor is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Caldolor's family patents as well as insights into ongoing legal events on those patents.
Caldolor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Caldolor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 16, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Caldolor Generic API suppliers:
Ibuprofen is the generic name for the brand Caldolor. 65 different companies have already filed for the generic of Caldolor, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Caldolor's generic
Alternative Brands for Caldolor
Caldolor which is used for management of pain, inflammation, fever, and patent ductus arteriosus with intravenous ibuprofen., has several other brand drugs using the same active ingredient (Ibuprofen). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
| Aft Pharms Us |
| |||||
| Bionpharma |
| |||||
| Haleon Us Holdings |
| |||||
| Hikma |
| |||||
| Horizon |
| |||||
| Kenvue Brands |
| |||||
| Recordati Rare |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ibuprofen, Caldolor's active ingredient. Check the complete list of approved generic manufacturers for Caldolor
About Caldolor
Caldolor is a drug owned by Cumberland Pharmaceuticals Inc. It is used for management of pain, inflammation, fever, and patent ductus arteriosus with intravenous ibuprofen. Caldolor uses Ibuprofen as an active ingredient. Caldolor was launched by Cumberland Pharms in 2009.
Approval Date:
Caldolor was approved by FDA for market use on 11 June, 2009.
Active Ingredient:
Caldolor uses Ibuprofen as the active ingredient. Check out other Drugs and Companies using Ibuprofen ingredient
Treatment:
Caldolor is used for management of pain, inflammation, fever, and patent ductus arteriosus with intravenous ibuprofen.
Dosage:
Caldolor is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG/200ML (4MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 800MG/8ML (100MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 400MG/4ML (100MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |