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
Versacloz US8057811 Stable clozapine suspension formulation May 01, 2028 Douglas Pharms
Fazaclo Odt US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Jazz
Fazaclo Odt US6221392 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



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 Clozapine's patents.

Given below is the list recent legal activities going on the following patents of Clozapine.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 10 May, 2023 US8057811
Payment of Maintenance Fee, 8th Year, Large Entity 07 Feb, 2019 US8057811
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 05 May, 2015 US8057811
Recordation of Patent Grant Mailed 15 Nov, 2011 US8057811
Patent Issue Date Used in PTA Calculation 15 Nov, 2011 US8057811
Email Notification 28 Oct, 2011 US8057811
Issue Notification Mailed 26 Oct, 2011 US8057811
Dispatch to FDC 14 Oct, 2011 US8057811
Application Is Considered Ready for Issue 11 Oct, 2011 US8057811
Issue Fee Payment Verified 23 Sep, 2011 US8057811


Clozapine's Family Patents

Family Patents

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Clozapine Generic API Manufacturers

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 Aurobindo Pharma Ltd and was approved on Dec 12, 2024.

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