Carac Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Carac.

Activity Date Patent Number
Patent litigations
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 24 Sep, 2013 US6670335 (Litigated)
Change in Power of Attorney (May Include Associate POA) 24 Sep, 2013 US6670335 (Litigated)
Correspondence Address Change 23 Sep, 2013 US6670335 (Litigated)
Change in Power of Attorney (May Include Associate POA) 13 Aug, 2009 US6670335 (Litigated)

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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


Family Patents

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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 Generics:

Fluorouracil is the generic name for the brand Carac. 22 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.

Drug Owner Drug Name Treatment Area
Bausch
Zyclara Used for treating skin conditions caused by certain types of viruses.
Leo Labs
Picato Used for treating actinic keratosis by inhibiting proliferative activity of neoplastic cells and stimulating the immune system.

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
Tolak


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