Sotalol Hydrochloride Patent Expiration

Sotalol Hydrochloride is used for treating life-threatening ventricular arrhythmias and maintaining normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter. It was first introduced by Legacy Pharma Inc in its drug Betapace on Oct 30, 1992. Other drugs containing Sotalol Hydrochloride are Betapace Af, Sotylize, Sotalol Hydrochloride. 16 different companies have introduced drugs containing Sotalol Hydrochloride.


Sotalol Hydrochloride Patents

Given below is the list of patents protecting Sotalol Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sotalol Hydrochloride US11583216 Method of administering sotalol IV/switch Aug 21, 2039 Altathera Pharms Llc
Sotalol Hydrochloride US10799138 Method of administering sotalol IV/switch Apr 05, 2039 Altathera Pharms Llc
Sotalol Hydrochloride US10512620 Method of initiating and escalating sotalol hydrochloride dosing Aug 14, 2038 Altathera Pharms Llc
Sotalol Hydrochloride US11696902 Method of initiating and escalating sotalol hydrochloride dosing Aug 14, 2038 Altathera Pharms Llc
Sotylize US9724297 Sotalol compositions and uses of the same Aug 31, 2035 Azurity
Sotylize US11850222 Sotalol compositions and uses of the same Nov 19, 2034 Azurity
Sotylize US10206895 Sotalol compositions and uses of the same Apr 01, 2034 Azurity
Sotylize US11013703 Sotalol compositions and uses of the same Apr 01, 2034 Azurity
Sotylize US12290495 Sotalol compositions and uses of the same Apr 01, 2034 Azurity



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.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 15 Apr, 2024 US10799138
Patent Issue Date Used in PTA Calculation 26 Dec, 2023 US11850222
Patent eGrant Notification 26 Dec, 2023 US11850222
Recordation of Patent eGrant 26 Dec, 2023 US11850222
Recordation of Patent Grant Mailed 26 Dec, 2023 US11850222
Email Notification 26 Dec, 2023 US11850222
Mail Patent eGrant Notification 26 Dec, 2023 US11850222
Email Notification 07 Dec, 2023 US11850222
Issue Notification Mailed 06 Dec, 2023 US11850222
Dispatch to FDC 13 Nov, 2023 US11850222


Sotalol Hydrochloride's Family Patents

Family Patents

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Sotalol Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Sotalol Hydrochloride. The first generic version for Sotalol Hydrochloride was by Esjay Pharma Llc and was approved on May 1, 2000. And the latest generic version is by Beximco Pharmaceuticals Usa Inc and was approved on Nov 2, 2018.

Given below is the list of companies who have filed for Sotalol Hydrochloride generic, along with the locations of their manufacturing plants worldwide.