Sotylize is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2017 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 31, 2035. Details of Sotylize'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). | |||
| US9724297 | Sotalol compositions and uses of the same |
Aug, 2035
(10 years from now) | Active |
| US11850222 | Sotalol compositions and uses of the same |
Nov, 2034
(9 years from now) | Active |
| US10206895 | Sotalol compositions and uses of the same |
Apr, 2034
(8 years from now) | Active |
| US11013703 | Sotalol compositions and uses of the same |
Apr, 2034
(8 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 Sotylize's patents.
Latest Legal Activities on Sotylize's Patents
Given below is the list of recent legal activities going on the following patents of Sotylize.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 26 Dec, 2023 | US11850222 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850222 |
| Email Notification Critical | 26 Dec, 2023 | US11850222 |
| Recordation of Patent Grant Mailed Critical | 26 Dec, 2023 | US11850222 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11850222 |
| Patent Issue Date Used in PTA Calculation Critical | 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 |
| Application Is Considered Ready for Issue Critical | 13 Nov, 2023 | US11850222 |
US patents provide insights into the exclusivity only within the United States, but Sotylize 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 Sotylize's family patents as well as insights into ongoing legal events on those patents.
Sotylize's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sotylize's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 31, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sotylize Generic API suppliers:
Sotalol Hydrochloride is the generic name for the brand Sotylize. 13 different companies have already filed for the generic of Sotylize, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sotylize's generic
Alternative Brands for Sotylize
Sotylize which is used for treating life-threatening ventricular arrhythmias and maintaining normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter., 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 | |
|---|---|---|
| Altathera Pharms Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sotalol Hydrochloride, Sotylize's active ingredient. Check the complete list of approved generic manufacturers for Sotylize
About Sotylize
Sotylize is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating life-threatening ventricular arrhythmias and maintaining normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter. Sotylize uses Sotalol Hydrochloride as an active ingredient. Sotylize was launched by Azurity in 2014.
Approval Date:
Sotylize was approved by FDA for market use on 22 October, 2014.
Active Ingredient:
Sotylize uses Sotalol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Sotalol Hydrochloride ingredient
Treatment:
Sotylize is used for treating life-threatening ventricular arrhythmias and maintaining normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter.
Dosage:
Sotylize is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/ML (5MG/ML) | SOLUTION | Prescription | ORAL |