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Zonisamide Patent Expiration

Zonisamide is Used for controlling seizures. It was first introduced by Advanz Pharma (Us) Corp in its drug Zonegran on Mar 27, 2000. Another drug containing Zonisamide is Zonisade. 20 different companies have introduced drugs containing Zonisamide.


Zonisamide Patents

Given below is the list of patents protecting Zonisamide, 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
Zonisade US11478456 Oral pharmaceutical composition comprising Zonisamide and process of preparation thereof Aug 18, 2038 Azurity
Zonisade US11529333 Oral pharmaceutical composition comprising zonisamide and process of preparation thereof Aug 18, 2038 Azurity



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 Zonisamide's patents.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed
Critical
 20 Dec, 2022 US11529333
Patent Issue Date Used in PTA Calculation
Critical
 20 Dec, 2022 US11529333
Email Notification
Critical
 01 Dec, 2022 US11529333
Issue Notification Mailed
Critical
 30 Nov, 2022 US11529333
Application Is Considered Ready for Issue
Critical
 23 Nov, 2022 US11529333
Dispatch to FDC 23 Nov, 2022 US11529333
Issue Fee Payment Verified
Critical
 02 Nov, 2022 US11529333
Issue Fee Payment Received
Critical
 02 Nov, 2022 US11529333
Recordation of Patent Grant Mailed
Critical
 25 Oct, 2022 US11478456
Patent Issue Date Used in PTA Calculation
Critical
 25 Oct, 2022 US11478456


Zonisamide's Family Patents

Family Patents

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Zonisamide Generic API Manufacturers

Several generic applications have been filed for Zonisamide. The first generic version for Zonisamide was by Roxane Laboratories Inc and was approved on Dec 22, 2005. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on May 12, 2025.

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


1. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005





2. APOTEX

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005


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
Toronto Apotex Inc.
Etobicoke Apotex, Inc.
Richmond Hill Apotex Inc.
Winnipeg Apotex Fermentation Inc.
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





3. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Zonisamide. 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
100MG

capsule Prescription ORAL AB Dec 22, 2005
50MG

capsule Prescription ORAL AB Sep 29, 2006
25MG

capsule Prescription ORAL AB Sep 29, 2006


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





4. BIONPHARMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Aug 16, 2006
100MG

capsule Prescription ORAL AB Aug 16, 2006
50MG

capsule Prescription ORAL AB Aug 16, 2006


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.





5. EPIC PHARMA LLC

Epic Pharma Llc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Feb 21, 2007
50MG

capsule Discontinued ORAL N/A Feb 21, 2007
100MG

capsule Discontinued ORAL N/A Feb 21, 2007





6. GLENMARK PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Jan 30, 2006
50MG

capsule Prescription ORAL AB Jan 30, 2006
100MG

capsule Prescription ORAL AB Jan 30, 2006





7. GRANULES

Granules India Ltd has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

capsule Prescription ORAL AB Dec 22, 2005
25MG

capsule Prescription ORAL AB Jul 27, 2006
50MG

capsule Prescription ORAL AB Jul 27, 2006


Manufacturing Plant Locations
New

Granules'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 Granules as present at those locations.

Country City Firm Name
United States
Manassas Granules Consumer Health Inc.
Chantilly Granules Pharmaceuticals Inc.
India
Secunderabad Granules India Limited
Parawada Mandal Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Visakhapatnam Granules India Limited
Sangareddy District Granules India Limited





8. HERITAGE PHARMA AVET

Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Heritage Pharma Avet.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Discontinued ORAL N/A Apr 20, 2006
25MG

capsule Discontinued ORAL N/A Apr 20, 2006
100MG

capsule Discontinued ORAL N/A Apr 20, 2006





9. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

capsule Prescription ORAL AB May 31, 2006
25MG

capsule Prescription ORAL AB May 31, 2006
50MG

capsule Prescription ORAL AB May 31, 2006





10. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB May 12, 2025
50MG

capsule Prescription ORAL AB May 12, 2025
100MG

capsule Prescription ORAL AB May 12, 2025





11. PHARMOBEDIENT

Pharmobedient Consulting Llc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Pharmobedient.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005





12. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
East Brunswick Rising Pharma Holding, Inc.
Fort Bragg Rising Tide Sea Vegetables
Phoenix Rising Sun Farms Inc
Decatur Rising Pharma Holdings, Inc
Mount Morris Rising Creek Bakery LLC
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





13. ROXANE

Roxane Laboratories Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Roxane.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005





14. SUN PHARM INDS (IN)

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds (in).

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Prescription ORAL AB Mar 17, 2006
25MG

capsule Prescription ORAL AB Mar 17, 2006
100MG

capsule Prescription ORAL AB Mar 17, 2006





15. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005
100MG

capsule Discontinued ORAL N/A Dec 22, 2005





16. UNICHEM

Unichem Laboratories Ltd has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

capsule Prescription ORAL AB Jan 26, 2021
25MG

capsule Prescription ORAL AB Jan 26, 2021
100MG

capsule Prescription ORAL AB Jan 26, 2021


Manufacturing Plant Locations
New

Unichem'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 Unichem as present at those locations.

Country City Firm Name
India
Pilerne Bardez Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
Kolhapur Unichem Laboratories Limited
Ghaziabad Unichem Laboratories Ltd.
Pithampur Unichem Laboratories Limited
United States
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc
East Brunswick Unichem Pharmaceuticals USA Inc.





17. UPSHER SMITH LABS

Upsher Smith Laboratories Llc has filed for 3 different strengths of generic version for Zonisamide. 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
100MG

capsule Discontinued ORAL N/A Dec 22, 2005
25MG

capsule Discontinued ORAL N/A Dec 22, 2005
50MG

capsule Discontinued ORAL N/A Dec 22, 2005





18. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 3 different strengths of generic version for Zonisamide. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

capsule Prescription ORAL AB Oct 16, 2006
50MG

capsule Prescription ORAL AB Oct 16, 2006
100MG

capsule Prescription ORAL AB Oct 16, 2006


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Moraiya, Ahmedabad Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
District Solan Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited