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 US4959366 Anti-arrhythmic agents Sep 25, 2012

(Expired)

Pfizer
Tikosyn US6124363 Dofetilide polymorphs Oct 09, 2018

(Expired)

Pfizer



Dofetilide Generics

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.


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


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


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


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


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


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


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


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