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 Sotalol Hydrochloride, Sotylize, Betapace Af. 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.
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.
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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.
1. 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
2. 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
Manufacturing Plant Locations
New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
Country
City
Firm Name
United States
Weston
Apotex Corp.
Canada
Brantford
Apotex Pharmachem Inc.
Etobicoke
Apotex, Inc.
North York
Apotex Inc.
Richmond Hill
Apotex Inc.
Toronto
Apotex Inc.
Winnipeg
Apotex Fermentation Inc.
India
Bangalore
Apotex Pharmachem India Pvt Ltd.
Bangalore
Apotex Research Private Limited - Bioequivalence Centre
Bengaluru
Apotex Research Private Limited
3. 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
Manufacturing Plant Locations
New
Aurobindo Pharma Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Usa as present at those locations.
Country
City
Firm Name
United States
East Windsor
Aurobindo Pharma USA Inc
4. 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
5. 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
6. ESJAY PHARMA
Esjay Pharma 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
Esjay Pharma.
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
7. 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
8. 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
9. 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
Manufacturing Plant Locations
New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
Country
City
Firm Name
United States
Phoenix
Rising Sun Farms Inc
Livingston
Risingsun Iodine Products Corp.
Rising Sun
Rising Sun Veterinary Clinic
Mount Morris
Rising Creek Bakery LLC
Decatur
Rising Pharma Holdings, Inc
East Brunswick
Rising Pharma Holding, Inc.
Flagstaff
Rising High Enterprises, LLC (DBA RisingHy)
Saddle Brook
Rising Pharmaceuticals, Inc.
Fort Bragg
Rising Tide Sea Vegetables
Mexico
Pueblo San Clemente
RISING FARMS SAPI DE CV
India
Ahmedabad
Rising Retina Clinic
10. 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
11. 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
Manufacturing Plant Locations
New
Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.
Country
City
Firm Name
United States
Malvern
Teva Branded Pharmaceutical Products R&D, Inc.
Horsham
Teva Branded Pharmaceutical Products R&D
Fort Dodge
TEVA Animal Health Inc
Miami
Teva Branded Pharmaceutical Products R & D, Inc.
India
Bhind
Teva API India Ltd- Malanpur
Gajraula, Amroha
Teva API India Private Ltd.
Canada
Markham
Teva Canada Limited
Scarborough
Teva Canada Limited
Stouffville
Teva Canada Limited
Czech Republic
Opava
Teva Czech Industries s.r.o.
Ireland
Dundalk
Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona
TEVA Medical Ltd.
12. 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
13. 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.
