Sotalol Hydrochloride is a drug owned by Altathera Pharmaceuticals Llc. It is protected by 4 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 21, 2039. Details of Sotalol Hydrochloride'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). | |||
| US11583216 | Method of administering sotalol IV/switch |
Aug, 2039
(14 years from now) | Active |
| US10799138 | Method of administering sotalol IV/switch |
Apr, 2039
(13 years from now) | Active |
| US11696902 | Method of initiating and escalating sotalol hydrochloride dosing |
Aug, 2038
(13 years from now) | Active |
| US10512620 | Method of initiating and escalating sotalol hydrochloride dosing |
Aug, 2038
(13 years 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 Sotalol Hydrochloride's patents.
Latest Legal Activities on Sotalol Hydrochloride's Patents
Given below is the list of recent legal activities going on the following patents of Sotalol Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 15 Apr, 2024 | US10799138 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Dec, 2023 | US11850222 |
| Patent eGrant Notification | 26 Dec, 2023 | US11850222 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11850222 |
| Recordation of Patent Grant Mailed Critical | 26 Dec, 2023 | US11850222 |
| Email Notification Critical | 26 Dec, 2023 | US11850222 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850222 |
| Email Notification Critical | 07 Dec, 2023 | US11850222 |
| Issue Notification Mailed Critical | 06 Dec, 2023 | US11850222 |
| Dispatch to FDC | 13 Nov, 2023 | US11850222 |
FDA has granted several exclusivities to Sotalol Hydrochloride. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sotalol Hydrochloride, 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 Sotalol Hydrochloride.
Exclusivity Information
Sotalol Hydrochloride holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Sotalol Hydrochloride's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jul 02, 2016 |
US patents provide insights into the exclusivity only within the United States, but Sotalol Hydrochloride 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 Sotalol Hydrochloride's family patents as well as insights into ongoing legal events on those patents.
Sotalol Hydrochloride's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sotalol Hydrochloride's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 21, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sotalol Hydrochloride Generic API suppliers:
Sotalol Hydrochloride is the generic name for the brand Sotalol Hydrochloride. 13 different companies have already filed for the generic of Sotalol Hydrochloride, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sotalol Hydrochloride's generic
Alternative Brands for Sotalol Hydrochloride
Sotalol Hydrochloride which is used for managing atrial fibrillation, atrial flutter, and life-threatening ventricular tachycardia., has several other brand drugs using the same active ingredient (Sotalol 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 | |
|---|---|---|
| Azurity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sotalol Hydrochloride, Sotalol Hydrochloride's active ingredient. Check the complete list of approved generic manufacturers for Sotalol Hydrochloride
About Sotalol Hydrochloride
Sotalol Hydrochloride is a drug owned by Altathera Pharmaceuticals Llc. It is used for managing atrial fibrillation, atrial flutter, and life-threatening ventricular tachycardia. Sotalol Hydrochloride uses Sotalol Hydrochloride as an active ingredient. Sotalol Hydrochloride was launched by Altathera Pharms Llc in 2009.
Approval Date:
Sotalol Hydrochloride was approved by FDA for market use on 02 July, 2009.
Active Ingredient:
Sotalol Hydrochloride uses Sotalol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Sotalol Hydrochloride ingredient
Treatment:
Sotalol Hydrochloride is used for managing atrial fibrillation, atrial flutter, and life-threatening ventricular tachycardia.
Dosage:
Sotalol Hydrochloride is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG/10ML (15MG/ML) | SOLUTION | Prescription | INTRAVENOUS |