Carac is a drug owned by Valeant Pharmaceuticals North America Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2021. Details of Carac'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). | |||
| US6670335 | Fluorouracil-containing formulation |
Jun, 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 Carac's patents.
Latest Legal Activities on Carac's Patents
Given below is the list of recent legal activities going on the following patents of Carac.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 17 May, 2017 | US6670335 (Litigated) |
| File Marked Found | 20 Dec, 2016 | US6670335 (Litigated) |
| File Marked Found | 01 Nov, 2016 | US6670335 (Litigated) |
| File Marked Found | 12 Jul, 2016 | US6670335 (Litigated) |
| File Marked Found | 21 Jan, 2016 | US6670335 (Litigated) |
| File Marked Found | 15 Jan, 2016 | US6670335 (Litigated) |
| Email Notification Critical | 24 Sep, 2013 | US6670335 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 24 Sep, 2013 | US6670335 (Litigated) |
| Correspondence Address Change Critical | 23 Sep, 2013 | US6670335 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Aug, 2009 | US6670335 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Carac 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 Carac's family patents as well as insights into ongoing legal events on those patents.
Carac's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Carac's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 02, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Carac Generic API suppliers:
Fluorouracil is the generic name for the brand Carac. 23 different companies have already filed for the generic of Carac, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Carac's generic
How can I launch a generic of Carac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Carac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Carac's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Carac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005 | 29 Jul, 2011 | 1 | 20 Apr, 2015 | 02 Jun, 2021 | Deferred |
Alternative Brands for Carac
Carac which is used for treating actinic keratosis., has several other brand drugs in the same treatment category and using the same active ingredient (Fluorouracil). 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.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Fluorouracil. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Hill Dermaceuticals |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluorouracil, Carac's active ingredient. Check the complete list of approved generic manufacturers for Carac
About Carac
Carac is a drug owned by Valeant Pharmaceuticals North America Llc. It is used for treating actinic keratosis. Carac uses Fluorouracil as an active ingredient. Carac was launched by Valeant Pharms North in 2000.
Approval Date:
Carac was approved by FDA for market use on 27 October, 2000.
Active Ingredient:
Carac uses Fluorouracil as the active ingredient. Check out other Drugs and Companies using Fluorouracil ingredient
Treatment:
Carac is used for treating actinic keratosis.
Dosage:
Carac is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5% | CREAM | Prescription | TOPICAL |