Caldolor Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6727286 Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Nov, 2021

(2 years ago)

Expired
US9649284 Treating critically ill patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US9114068 Treating patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US8735452 Treating patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US9295639 Treating critically ill patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US9138404 Treating critically ill patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US8871810 Treating critically ill patients with intravenous ibuprofen
Sep, 2029

(5 years from now)

Active
US9012508 Administration of intravenous ibuprofen
Sep, 2030

(6 years from now)

Active
US9072661 Injectable ibuprofen formulation
Mar, 2032

(7 years from now)

Active
US9072710 Injectable ibuprofen formulation
Mar, 2032

(7 years from now)

Active
US11806400 Injectable ibuprofen formulation
Mar, 2032

(7 years from now)

Active


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 has 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 or infringement 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
Patent litigations
US9295639 December, 2012 Decision 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 2 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Caldolor has patent protection in a total of 15 countries. It's US patent count contributes only to 34.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Caldolor.

Family Patents

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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 Generics:

Ibuprofen is the generic name for the brand Caldolor. 63 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





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.

Market Authorisation 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/8ML (100MG/ML) SOLUTION Prescription INTRAVENOUS
400MG/4ML (100MG/ML) SOLUTION Discontinued INTRAVENOUS
800MG/200ML (4MG/ML) SOLUTION Prescription INTRAVENOUS