Clorotekal is a drug owned by B Braun Medical Inc. It is protected by 2 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2033. Details of Clorotekal'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). | |||
| US9504666 | Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration |
Dec, 2033
(9 years from now) | Active |
| US8969412 | Use for a composition comprising chloroprocaine HCL, a new composition comprising chloroprocaine HCL and a method for its manufacture |
Sep, 2026
(1 year, 9 months from now) | Active |
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 Clorotekal's patents.
Latest Legal Activities on Clorotekal's Patents
Given below is the list of recent legal activities going on the following patents of Clorotekal.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 15 May, 2024 | US9504666 |
| Correspondence Address Change Critical | 10 Nov, 2022 | US8969412 |
| Correspondence Address Change Critical | 09 Nov, 2022 | US8969412 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 Aug, 2022 | US8969412 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 14 May, 2020 | US9504666 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 23 Aug, 2018 | US8969412 |
| Recordation of Patent Grant Mailed Critical | 29 Nov, 2016 | US9504666 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Nov, 2016 | US9504666 |
| Email Notification Critical | 10 Nov, 2016 | US9504666 |
| Issue Notification Mailed Critical | 09 Nov, 2016 | US9504666 |
FDA has granted several exclusivities to Clorotekal. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Clorotekal, 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 Clorotekal.
Exclusivity Information
Clorotekal holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Clorotekal's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 26, 2020 |
US patents provide insights into the exclusivity only within the United States, but Clorotekal 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 Clorotekal's family patents as well as insights into ongoing legal events on those patents.
Clorotekal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clorotekal's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clorotekal Generic API suppliers:
Chloroprocaine Hydrochloride is the generic name for the brand Clorotekal. 2 different companies have already filed for the generic of Clorotekal, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clorotekal's generic
Alternative Brands for Clorotekal
Clorotekal which is used for regional anesthesia through intrathecal administration., has several other brand drugs using the same active ingredient (Chloroprocaine Hydrochloride). 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 | |
|---|---|---|
| Harrow Eye |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Chloroprocaine Hydrochloride, Clorotekal's active ingredient. Check the complete list of approved generic manufacturers for Clorotekal
About Clorotekal
Clorotekal is a drug owned by B Braun Medical Inc. It is used for regional anesthesia through intrathecal administration. Clorotekal uses Chloroprocaine Hydrochloride as an active ingredient. Clorotekal was launched by B Braun Medical Inc in 2017.
Approval Date:
Clorotekal was approved by FDA for market use on 26 September, 2017.
Active Ingredient:
Clorotekal uses Chloroprocaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Chloroprocaine Hydrochloride ingredient
Treatment:
Clorotekal is used for regional anesthesia through intrathecal administration.
Dosage:
Clorotekal is available in solution form for intrathecal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/5ML (10MG/ML) | SOLUTION | Discontinued | INTRATHECAL |