Tolak is a drug owned by Hill Dermaceuticals Inc. It is protected by 1 US drug patent filed in 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2023. Details of Tolak'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). | |||
| US7169401 | Topical skin care composition containing refined peanut oil |
Jul, 2023
(2 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 Tolak's patents.
Latest Legal Activities on Tolak's Patents
Given below is the list of recent legal activities going on the following patents of Tolak.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail-Record Petition Decision of Granted to Make Entity Status large | 29 Aug, 2019 | US7169401 |
| Mail O.P. Petition Decision | 29 Aug, 2019 | US7169401 |
| Record Petition Decision of Granted to Make Entity Status large | 28 Aug, 2019 | US7169401 |
| O.P. Petition Decision | 28 Aug, 2019 | US7169401 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 28 Aug, 2019 | US7169401 |
| Petition Entered | 30 Jan, 2019 | US7169401 |
| Payment of Maintenance Fee under 1.28(c) | 30 Jan, 2019 | US7169401 |
| Refund - Payment of Maintenance Fee under 1.28(c) | 30 Jan, 2019 | US7169401 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 26 Jul, 2018 | US7169401 |
| Notice of Final Determination- Ineligible | 02 Mar, 2017 | US7169401 |
FDA has granted several exclusivities to Tolak. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Tolak, 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
Tolak.
Exclusivity Information
Tolak holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Tolak's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 18, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Tolak 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 Tolak's family patents as well as insights into
ongoing legal events
on those patents.
Tolak's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tolak's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tolak Generic API suppliers:
Fluorouracil is the generic name for the brand Tolak. 23 different companies have already filed for the generic of Tolak, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tolak's generic
Alternative Brands for Tolak
There are several other brand drugs using the same active ingredient (Fluorouracil) as Tolak. 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 | |
|---|---|---|
| Extrovis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluorouracil, Tolak's active ingredient. Check the complete list of approved generic manufacturers for Tolak
About Tolak
Tolak is a drug owned by Hill Dermaceuticals Inc. Tolak uses Fluorouracil as an active ingredient. Tolak was launched by Hill Dermaceuticals in 2015.
Approval Date:
Tolak was approved by FDA for market use on 18 September, 2015.
Active Ingredient:
Tolak uses Fluorouracil as the active ingredient. Check out other Drugs and Companies using Fluorouracil ingredient
Dosage:
Tolak is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4% | CREAM | Prescription | TOPICAL |