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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.

Event Date Patent/Publication
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



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Clobazam Generics

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.


1. 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


2. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. 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


15. CELLTRION

Celltrion 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 Celltrion.

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


16. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG/ML suspension Discontinued ORAL N/A Oct 22, 2018


17. 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


18. 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


19. 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


20. PIRAMAL HLTHCARE UK

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 Hlthcare Uk.

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


21. 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


22. 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