Clobazam Patent Expiration

Clobazam is Used for managing seizure disorders. It was first introduced by Lundbeck Pharmaceuticals Llc in its drug Onfi on Oct 21, 2011. Another drug containing Clobazam is Sympazan. 24 different companies have introduced drugs containing Clobazam.


Clobazam Patents

Given below is the list of patents protecting Clobazam, 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
Sympazan US11541002 Oral film compositions and dosage forms having precise active dissolution profiles Jan 31, 2040 Otter Pharms
Sympazan US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Apr 03, 2024

(Expired)

Otter Pharms
Sympazan US8765167 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Feb 20, 2024

(Expired)

Otter Pharms



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 Clobazam's patents.

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

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 03 Jan, 2023 US11541002
Recordation of Patent Grant Mailed 03 Jan, 2023 US11541002
Issue Notification Mailed 14 Dec, 2022 US11541002
Application Is Considered Ready for Issue 29 Nov, 2022 US11541002
Dispatch to FDC 29 Nov, 2022 US11541002
Workflow - Drawings Finished 28 Nov, 2022 US11541002
PUB Other miscellaneous communication to applicant 03 Nov, 2022 US11541002
Mail PUB other miscellaneous communication to applicant 03 Nov, 2022 US11541002
Issue Fee Payment Received 27 Oct, 2022 US11541002
Issue Fee Payment Verified 27 Oct, 2022 US11541002


Clobazam's Family Patents

Family Patents

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Clobazam Generic API Manufacturers

Several generic applications have been filed for Clobazam. The first generic version for Clobazam was by Bionpharma Inc and was approved on Oct 22, 2018. And the latest generic version is by Accord Healthcare Inc and was approved on Sep 6, 2022.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 3 different strengths of generic version for Clobazam. 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
10MG

tablet Discontinued ORAL N/A May 23, 2019
20MG

tablet Discontinued ORAL N/A May 23, 2019
2.5MG/ML

suspension Discontinued ORAL N/A Sep 6, 2022





2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 4 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Sep 6, 2019
20MG

tablet Prescription ORAL AB Sep 6, 2019
5MG

tablet Prescription ORAL N/A Dec 21, 2020
2.5MG/ML

suspension Prescription ORAL AB May 6, 2021





3. AMNEAL

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML

suspension Prescription ORAL AB Oct 22, 2018


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





4. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 22, 2018
20MG

tablet Prescription ORAL AB Oct 22, 2018





5. ANDA REPOSITORY

Anda Repository Llc has filed for 2 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Anda Repository.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Dec 9, 2020
10MG

tablet Discontinued ORAL N/A Dec 9, 2020





6. APOTEX

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Jun 9, 2020
20MG

tablet Discontinued ORAL N/A Jun 9, 2020


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Clobazam. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML

suspension Prescription ORAL AB Mar 24, 2022


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





8. BIONPHARMA

Bionpharma Inc has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 22, 2018
20MG

tablet Prescription ORAL AB Oct 22, 2018
2.5MG/ML

suspension Prescription ORAL AB Oct 22, 2018


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





9. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 22, 2018
20MG

tablet Discontinued ORAL N/A Oct 22, 2018
5MG

tablet Discontinued ORAL N/A Oct 19, 2021


Manufacturing Plant Locations
New

Breckenridge'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 Breckenridge as present at those locations.

Country City Firm Name
United States
Boca Raton Breckenridge Pharmaceutical, Inc.
Berlin Breckenridge Pharmaceutical, Inc





10. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Oct 30, 2019
20MG

tablet Discontinued ORAL N/A Oct 30, 2019
2.5MG/ML

suspension Prescription ORAL AB Apr 24, 2020





11. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Oct 22, 2018
10MG

tablet Prescription ORAL AB Oct 22, 2018
2.5MG/ML

suspension Prescription ORAL AB Feb 24, 2020





12. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML

suspension Discontinued ORAL N/A Oct 22, 2018
10MG

tablet Discontinued ORAL N/A Oct 22, 2018
20MG

tablet Discontinued ORAL N/A Oct 22, 2018


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





13. LUPIN LTD

Lupin Ltd has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Dec 14, 2018
20MG

tablet Prescription ORAL AB Dec 14, 2018
2.5MG/ML

suspension Prescription ORAL AB Dec 28, 2018


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





14. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Jan 30, 2019
20MG

tablet Prescription ORAL AB Jan 30, 2019


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Bangalore Micro Labs Limited
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory





15. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB May 11, 2021
20MG

tablet Prescription ORAL AB May 11, 2021


Manufacturing Plant Locations
New

Msn'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 Msn as present at those locations.

Country City Firm Name
India
Yadadri Bhuvanagiri District MSN Organics Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Pharmachem Private Limited
Kamareddy MSN Life Sciences Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





16. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Clobazam. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML

suspension Discontinued ORAL N/A Oct 22, 2018





17. PIRAMAL

Piramal Healthcare Uk Ltd has filed for 2 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Piramal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 22, 2018
20MG

tablet Prescription ORAL AB Oct 22, 2018





18. TARO

Taro Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Oct 22, 2018
20MG

tablet Discontinued ORAL N/A Oct 22, 2018
2.5MG/ML

suspension Prescription ORAL AB Apr 15, 2019


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





19. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Clobazam. 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
2.5MG/ML

suspension Discontinued ORAL N/A Jan 31, 2020





20. UPSHER SMITH LABS

Upsher Smith Laboratories Llc has filed for 3 different strengths of generic version for Clobazam. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 22, 2018
20MG

tablet Prescription ORAL AB Oct 22, 2018
2.5MG/ML

suspension Discontinued ORAL N/A Oct 22, 2018





21. VISTAPHARM

Vistapharm Inc has filed for 1 generic for Clobazam. Given below are the details of the strengths of this generic introduced by Vistapharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML

suspension Discontinued ORAL N/A Jul 10, 2019





22. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Clobazam. 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
20MG

tablet Prescription ORAL AB Oct 22, 2018
10MG

tablet Prescription ORAL AB Oct 22, 2018