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Dofetilide Patent Expiration

Dofetilide is Used for treating cardiac arrhythmia. It was first introduced by Pfizer Pharmaceuticals Production Corp Ltd in its drug Tikosyn on Oct 1, 1999. 14 different companies have introduced drugs containing Dofetilide.


Dofetilide Patents

Given below is the list of patents protecting Dofetilide, 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
Tikosyn US6124363 Dofetilide polymorphs Oct 09, 2018

(Expired)

 Pfizer
Tikosyn US4959366 Anti-arrhythmic agents Sep 25, 2012

(Expired)

 Pfizer



Dofetilide's Family Patents

Family Patents

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Dofetilide Generic API Manufacturers

Several generic applications have been filed for Dofetilide. The first generic version for Dofetilide was by Dr Reddys Laboratories Sa and was approved on Jun 6, 2016. And the latest generic version is by Teva Pharmaceuticals Usa Inc and was approved on Apr 15, 2022.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Jun 19, 2020
0.25MG

capsule Prescription ORAL AB Jun 19, 2020
0.5MG

capsule Prescription ORAL AB Jun 19, 2020





2. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Dofetilide. All of these versions come by the name DOFETILDE. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Jan 22, 2019
0.5MG

capsule Prescription ORAL AB Jan 22, 2019
0.25MG

capsule Prescription ORAL AB Jan 22, 2019


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





3. BIONPHARMA

Bionpharma Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Apr 10, 2018
0.5MG

capsule Prescription ORAL AB Apr 10, 2018
0.25MG

capsule Prescription ORAL AB Apr 10, 2018


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





4. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Jun 6, 2016
0.25MG

capsule Prescription ORAL AB Jun 6, 2016
0.5MG

capsule Prescription ORAL AB Jun 6, 2016





5. GRANULES

Granules Pharmaceuticals Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Oct 14, 2021
0.25MG

capsule Prescription ORAL AB Oct 14, 2021
0.125MG

capsule Prescription ORAL AB Oct 14, 2021


Manufacturing Plant Locations
New

Granules's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Granules as present at those locations.

Country City Firm Name
United States
Manassas Granules Consumer Health Inc.
Chantilly Granules Pharmaceuticals Inc.
India
Parawada Mandal Granules India Limited
Secunderabad Granules India Limited
Visakhapatnam Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Sangareddy District Granules India Limited





6. MSN

Msn Laboratories Private Ltd has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Jan 29, 2020
0.25MG

capsule Prescription ORAL AB Jan 29, 2020
0.125MG

capsule Prescription ORAL AB Jan 29, 2020


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Yadadri Bhuvanagiri District MSN Organics Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Sangareddy MSN Pharmachem Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Rangareddy District MSN Laboratories Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Kamareddy MSN Life Sciences Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





7. NOVAST LABS

Novast Laboratories Ltd has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Discontinued ORAL N/A Dec 27, 2019
0.25MG

capsule Discontinued ORAL N/A Dec 27, 2019
0.5MG

capsule Discontinued ORAL N/A Dec 27, 2019





8. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Discontinued ORAL N/A Dec 17, 2019
0.125MG

capsule Discontinued ORAL N/A Dec 17, 2019
0.25MG

capsule Discontinued ORAL N/A Dec 17, 2019





9. RK PHARMA

Rk Pharma Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Rk Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

capsule Discontinued ORAL N/A Apr 14, 2022
0.5MG

capsule Discontinued ORAL N/A Apr 14, 2022
0.125MG

capsule Discontinued ORAL N/A Apr 14, 2022


Manufacturing Plant Locations
New

Rk Pharma'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 Rk Pharma as present at those locations.

Country City Firm Name
United States
Pearl River RK Pharma Inc.





10. SIGMAPHARM LABS LLC

Sigmapharm Laboratories Llc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Sigmapharm Labs Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Mar 26, 2018
0.25MG

capsule Prescription ORAL AB Mar 26, 2018
0.5MG

capsule Prescription ORAL AB Mar 26, 2018





11. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.125MG

capsule Prescription ORAL AB Oct 9, 2018
0.25MG

capsule Prescription ORAL AB Oct 9, 2018
0.5MG

capsule Prescription ORAL AB Oct 9, 2018


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





12. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

capsule Prescription ORAL AB Oct 9, 2018
0.125MG

capsule Prescription ORAL AB Oct 9, 2018
0.25MG

capsule Prescription ORAL AB Oct 9, 2018


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Vadodara Sun Pharmaceutical Industries Ltd.
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Dadra Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Ahmednagar Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Halol Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited





13. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Dofetilide. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

capsule Discontinued ORAL N/A Apr 15, 2022
0.5MG

capsule Discontinued ORAL N/A Apr 15, 2022
0.125MG

capsule Discontinued ORAL N/A Apr 15, 2022