Clozapine Patent Expiration

Clozapine was first introduced by Heritage Life Sciences Barbados Inc in its drug Clozaril on Sep 26, 1989. Other drugs containing Clozapine are Versacloz, Fazaclo Odt. 14 different companies have introduced drugs containing Clozapine.


Clozapine Patents

Given below is the list of patents protecting Clozapine, 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
Fazaclo Odt US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Jazz
Fazaclo Odt US6106861 Multiparticulate tablet disintegrating in less than 40 seconds in the mouth Dec 05, 2017

(Expired)

Jazz
Fazaclo Odt US6221392 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Jazz
Versacloz US8057811 Stable clozapine suspension formulation May 01, 2028 Tasman Pharma


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Clozapine Generics

Several generic applications have been filed for Clozapine. The first generic version for Clozapine was by Sandoz Inc and was approved on Aug 30, 1996. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Aug 7, 2023.

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


1. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Dec 6, 2017
200MG tablet Discontinued ORAL N/A Dec 6, 2017
25MG tablet Discontinued ORAL N/A Dec 6, 2017
100MG tablet Discontinued ORAL N/A Dec 6, 2017


2. PAR PHARM

Par Pharmaceutical has filed for 2 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Par Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Apr 26, 2005
100MG tablet Discontinued ORAL N/A Apr 26, 2005


3. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Clozapine. 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
150MG tablet, orally disintegrating Prescription ORAL AB Nov 25, 2015
200MG tablet, orally disintegrating Prescription ORAL AB Nov 25, 2015


4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Prescription ORAL AB Nov 29, 2016
25MG tablet Prescription ORAL AB Nov 29, 2016
200MG tablet Prescription ORAL AB Nov 29, 2016
50MG tablet Prescription ORAL AB Nov 29, 2016


5. MYLAN

Mylan Pharmaceuticals Inc has filed for 6 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, orally disintegrating Prescription ORAL AB Sep 15, 2015
25MG tablet, orally disintegrating Prescription ORAL AB Sep 15, 2015
50MG tablet Prescription ORAL AB Apr 15, 2010
12.5MG tablet Discontinued ORAL N/A Apr 15, 2010
200MG tablet, orally disintegrating Prescription ORAL AB Aug 7, 2023
150MG tablet, orally disintegrating Prescription ORAL AB Aug 7, 2023


6. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 4 different strengths of generic version for Clozapine. 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
25MG tablet Discontinued ORAL N/A Sep 17, 2015
100MG tablet Discontinued ORAL N/A Sep 17, 2015
50MG tablet Discontinued ORAL N/A Aug 22, 2017
200MG tablet Discontinued ORAL N/A Aug 22, 2017


7. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Clozapine. 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
25MG tablet Prescription ORAL AB Nov 25, 2015
100MG tablet Prescription ORAL AB Nov 25, 2015


8. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 4 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Nov 15, 2002
100MG tablet Prescription ORAL AB Nov 15, 2002
50MG tablet Prescription ORAL AB Aug 19, 2005
200MG tablet Prescription ORAL AB Nov 7, 2017


9. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Discontinued ORAL N/A Aug 30, 1996
25MG tablet Discontinued ORAL N/A Aug 30, 1996


10. BARR LABS INC

Barr Laboratories Inc has filed for 3 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Barr Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet, orally disintegrating Prescription ORAL AB Nov 25, 2015
100MG

(reference standard)

tablet, orally disintegrating Prescription ORAL AB Nov 25, 2015
12.5MG tablet, orally disintegrating Prescription ORAL N/A Apr 9, 2018


11. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 5 different strengths of generic version for Clozapine. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Prescription ORAL AB Dec 16, 2005
25MG tablet Prescription ORAL AB Nov 26, 1997
12.5MG tablet Prescription ORAL N/A Jul 31, 2003
50MG tablet Prescription ORAL AB Dec 16, 2005
200MG tablet Prescription ORAL AB Dec 16, 2005