Sotylize Patent Expiration

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

(10 years from now)

Active
US10206895 Sotalol compositions and uses of the same
Apr, 2034

(9 years from now)

Active
US11013703 Sotalol compositions and uses of the same
Apr, 2034

(9 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.

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

Activity Date Patent Number
Patent litigations
Patent eGrant Notification 26 Dec, 2023 US11850222
Mail Patent eGrant Notification 26 Dec, 2023 US11850222
Email Notification 26 Dec, 2023 US11850222
Recordation of Patent Grant Mailed 26 Dec, 2023 US11850222
Recordation of Patent eGrant 26 Dec, 2023 US11850222
Patent Issue Date Used in PTA Calculation 26 Dec, 2023 US11850222
Email Notification 07 Dec, 2023 US11850222
Issue Notification Mailed 06 Dec, 2023 US11850222
Dispatch to FDC 13 Nov, 2023 US11850222
Application Is Considered Ready for Issue 13 Nov, 2023 US11850222

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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

Sotylize has patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Sotylize.

Family Patents

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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
Sotalol Hydrochloride


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