Nizatidine Patent Expiration

Nizatidine was first introduced by Smithkline Beecham Corp Dba Glaxosmithkline in its drug Axid on Apr 12, 1988. Another drug containing Nizatidine is Axid Ar. 11 different companies have introduced drugs containing Nizatidine.


Nizatidine Patents

Given below is the list of patents protecting Nizatidine, 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
Axid US6930119 Liquid pharmaceutical composition Jul 17, 2022

(Expired)

Braintree


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Nizatidine Generics

Several generic applications have been filed for Nizatidine. The first generic version for Nizatidine was by Mylan Pharmaceuticals Inc. and was approved on Jul 5, 2002. And the latest generic version is by Glenmark Pharmaceuticals Inc Usa and was approved on Jul 15, 2011.

Given below is the list of companies who have filed for Nizatidine generic.


1. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc. has filed for 2 different strengths of generic version for Nizatidine. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG capsule Discontinued ORAL N/A Jul 9, 2002
150MG capsule Discontinued ORAL N/A Jul 9, 2002


2. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 2 different strengths of generic version for Nizatidine. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG capsule Discontinued ORAL N/A Sep 12, 2002
300MG capsule Discontinued ORAL N/A Sep 12, 2002


3. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Nizatidine. 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
300MG

(reference standard)

capsule Prescription ORAL AB Jul 9, 2002
150MG capsule Prescription ORAL AB Jul 9, 2002


4. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Nizatidine. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG capsule Prescription ORAL AB Sep 15, 2005
300MG capsule Prescription ORAL AB Sep 15, 2005


5. APOTEX INC

Apotex Inc has filed for 2 different strengths of generic version for Nizatidine. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG capsule Discontinued ORAL N/A Jan 23, 2003
300MG capsule Discontinued ORAL N/A Jan 23, 2003


6. GLENMARK PHARMS INC

Glenmark Pharmaceuticals Inc Usa has filed for 2 different strengths of generic version for Nizatidine. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
150MG capsule Prescription ORAL AB Jul 15, 2011
300MG capsule Prescription ORAL AB Jul 15, 2011


7. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Nizatidine. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MG/ML solution Discontinued ORAL N/A Nov 18, 2009


8. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Nizatidine. 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
150MG capsule Prescription ORAL AB Jul 5, 2002
300MG capsule Prescription ORAL AB Jul 5, 2002