Clozapine Patent Expiration
Clozapine was first introduced by Heritage Life Sciences Barbados Inc
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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical
| 15 Nov, 2011 | US8057811 |
| Patent Issue Date Used in PTA Calculation Critical
| 15 Nov, 2011 | US8057811 |
| Email Notification Critical
| 28 Oct, 2011 | US8057811 |
| Issue Notification Mailed Critical
| 26 Oct, 2011 | US8057811 |
| Dispatch to FDC | 14 Oct, 2011 | US8057811 |
| Application Is Considered Ready for Issue Critical
| 11 Oct, 2011 | US8057811 |
| Issue Fee Payment Verified Critical
| 23 Sep, 2011 | US8057811 |
Clozapine's Family Patents
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Clinical Trials
Recent Clinical Trials on Clozapine:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective. | Rakitzi, Stavroula | NA |
COMPLETED
(Aug 1, 2026)
| PHASE1 |
| ZR001 Chemogenetics Gene Therapy Study in Patients With Parkinson's Disease | Qianfoshan Hospital | NA |
NOT YET RECRUITING
(Jul 1, 2026)
| PHASE1 |
| Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia | Virginia Commonwealth University | NA |
RECRUITING
(Jun 1, 2026)
| PHASE2 |
| No Guts No Glory Probiotics | University Medical Center Groningen | NA |
RECRUITING
(May 1, 2026)
| PHASE2, PHASE3 |
| Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia | China Medical University Hospital | NA |
RECRUITING
(Mar 1, 2026)
| PHASE2 |