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
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 | US10512620 | Method of initiating and escalating sotalol hydrochloride dosing | Aug 14, 2038 | Altathera Pharms Llc |
| Sotalol Hydrochloride | US10799138 | Method of administering sotalol IV/switch | Apr 05, 2039 | Altathera Pharms Llc |
| Sotalol Hydrochloride | US11583216 | Method of administering sotalol IV/switch | Aug 21, 2039 | Altathera Pharms Llc |
| Sotalol Hydrochloride | US11696902 | Method of initiating and escalating sotalol hydrochloride dosing | Aug 14, 2038 | Altathera Pharms Llc |
| 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 | US11850222 | Sotalol compositions and uses of the same | Nov 19, 2034 | Azurity |
| Sotylize | US9724297 | Sotalol compositions and uses of the same | Aug 31, 2035 | 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.
Latest Legal Activities on Sotalol Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Sotalol Hydrochloride.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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Sotalol Hydrochloride Generics
Several generic applications have been filed for Sotalol Hydrochloride. The first generic version for Sotalol Hydrochloride was by Natco Pharma Usa 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.
1. OXFORD PHARMS
Oxford Pharmaceuticals Llc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Oxford Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 160MG | tablet | Prescription | ORAL | AB | Nov 7, 2003 |
| 120MG | tablet | Prescription | ORAL | AB | Nov 7, 2003 |
| 80MG | tablet | Prescription | ORAL | AB | Nov 7, 2003 |
| 240MG | tablet | Prescription | ORAL | AB | Nov 7, 2003 |
2. AIPING PHARM INC
Aiping Pharmaceutical Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. All of these versions come by the name SORINE. Given below are the details of the strengths of this generic introduced by Aiping Pharm Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Apr 27, 2001 |
| 160MG | tablet | Prescription | ORAL | AB | Apr 27, 2001 |
| 240MG | tablet | Prescription | ORAL | AB | Apr 27, 2001 |
| 120MG | tablet | Prescription | ORAL | AB | Apr 27, 2001 |
3. BEXIMCO PHARMS USA
Beximco Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Beximco Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 160MG | tablet | Prescription | ORAL | AB | Nov 2, 2018 |
| 80MG | tablet | Prescription | ORAL | AB | Nov 2, 2018 |
| 120MG | tablet | Prescription | ORAL | AB | Nov 2, 2018 |
4. RISING
Rising Pharma Holdings Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 240MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2000 |
| 80MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2000 |
| 120MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2000 |
| 160MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2000 |
5. UPSHER SMITH LABS
Upsher Smith Laboratories Llc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 160MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 240MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 80MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
6. WATSON LABS
Watson Laboratories Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2000 |
| 120MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2000 |
| 160MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2000 |
| 240MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2000 |
7. AUROBINDO PHARMA USA
Aurobindo Pharma Usa Inc has filed for 3 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Feb 7, 2007 |
| 120MG | tablet | Prescription | ORAL | AB | Feb 7, 2007 |
| 160MG | tablet | Prescription | ORAL | AB | Feb 7, 2007 |
8. TEVA
Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Discontinued | ORAL | N/A | Jul 26, 2004 |
| 160MG | tablet | Discontinued | ORAL | N/A | Jul 26, 2004 |
| 240MG | tablet | Prescription | ORAL | AB | May 1, 2000 |
| 120MG | tablet | Discontinued | ORAL | N/A | Jul 26, 2004 |
9. SUN PHARM INDUSTRIES
Sun Pharmaceutical Industries Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Discontinued | ORAL | N/A | Apr 8, 2004 |
| 120MG | tablet | Discontinued | ORAL | N/A | Apr 8, 2004 |
| 240MG | tablet | Discontinued | ORAL | N/A | Oct 15, 2001 |
| 160MG | tablet | Discontinued | ORAL | N/A | Apr 8, 2004 |
10. EPIC PHARMA LLC
Epic Pharma Llc has filed for 3 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 160MG | tablet | Prescription | ORAL | AB | Nov 4, 2005 |
| 80MG | tablet | Prescription | ORAL | AB | Nov 4, 2005 |
| 120MG | tablet | Prescription | ORAL | AB | Nov 4, 2005 |
11. IMPAX PHARMS
Impax Pharmaceuticals has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 240MG | tablet | Discontinued | ORAL | N/A | Nov 7, 2000 |
| 80MG | tablet | Discontinued | ORAL | N/A | Nov 7, 2000 |
| 120MG | tablet | Discontinued | ORAL | N/A | Nov 7, 2000 |
| 160MG | tablet | Discontinued | ORAL | N/A | Nov 7, 2000 |
12. APOTEX
Apotex Inc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 80MG | tablet | Prescription | ORAL | AB | Aug 27, 2003 |
| 240MG | tablet | Prescription | ORAL | AB | Sep 26, 2002 |
| 160MG | tablet | Prescription | ORAL | AB | Aug 27, 2003 |
| 120MG | tablet | Prescription | ORAL | AB | Aug 27, 2003 |
13. NATCO PHARMA USA
Natco Pharma Usa Llc has filed for 4 different strengths of generic version for Sotalol Hydrochloride. Given below are the details of the strengths of this generic introduced by Natco Pharma Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 120MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 160MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 240MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |
| 80MG | tablet | Discontinued | ORAL | N/A | May 1, 2000 |