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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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.
1. 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 |
2. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 6 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 |
|---|---|---|---|---|---|
| 200MG | tablet, orally disintegrating | Prescription | ORAL | AB | Dec 12, 2024 |
| 100MG | tablet, orally disintegrating | Prescription | ORAL | AB | Dec 12, 2024 |
| 50MG | tablet | Prescription | ORAL | AB | Nov 29, 2016 |
| 25MG | tablet, orally disintegrating | Prescription | ORAL | AB | Dec 12, 2024 |
| 150MG | tablet, orally disintegrating | Prescription | ORAL | AB | Dec 12, 2024 |
| 12.5MG | tablet, orally disintegrating | Prescription | ORAL | AB | Dec 12, 2024 |
Manufacturing Plant Locations New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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3. BARR LABS INC
Barr Laboratories Inc has filed for 5 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 |
| 150MG | tablet, orally disintegrating | Prescription | ORAL | AB | Nov 25, 2015 |
| 200MG | tablet, orally disintegrating | Prescription | ORAL | AB | Nov 25, 2015 |
| 12.5MG | tablet, orally disintegrating | Prescription | ORAL | AB | Apr 9, 2018 |
4. 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 |
5. 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 |
6. 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 |
| 200MG | tablet, orally disintegrating | Prescription | ORAL | AB | Aug 7, 2023 |
| 12.5MG | tablet | Discontinued | ORAL | N/A | Apr 15, 2010 |
| 50MG | tablet | Prescription | ORAL | AB | Apr 15, 2010 |
| 150MG | tablet, orally disintegrating | Prescription | ORAL | AB | Aug 7, 2023 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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7. 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 |
Manufacturing Plant Locations New
Par Pharm's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Par Pharm as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
8. 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 |
|---|---|---|---|---|---|
| 25MG | tablet | Discontinued | ORAL | N/A | Aug 30, 1996 |
| 100MG | tablet | Discontinued | ORAL | N/A | Aug 30, 1996 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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9. 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 |
|---|---|---|---|---|---|
| 100MG | tablet | Discontinued | ORAL | N/A | Nov 15, 2002 |
| 25MG | tablet | Discontinued | ORAL | N/A | Nov 15, 2002 |
| 50MG | tablet | Discontinued | ORAL | N/A | Aug 19, 2005 |
| 200MG | tablet | Discontinued | ORAL | N/A | Nov 7, 2017 |
10. 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 |
11. 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 |
|---|---|---|---|---|---|
| 25MG | tablet | Discontinued | ORAL | N/A | Dec 6, 2017 |
| 200MG | tablet | Discontinued | ORAL | N/A | Dec 6, 2017 |
| 100MG | tablet | Discontinued | ORAL | N/A | Dec 6, 2017 |
| 50MG | tablet | Discontinued | ORAL | N/A | Dec 6, 2017 |