Temozolomide Patent Expiration

Temozolomide is Used for treating malignant neoplasms. It was first introduced by Merck Sharp And Dohme Corp in its drug Temodar on Aug 11, 1999. 17 different companies have introduced drugs containing Temozolomide.


Temozolomide Patents

Given below is the list of patents protecting Temozolomide, 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
Temodar US6987108 Pharmaceutical formulations of antineoplastic agents and processes of making and using the same Sep 08, 2023

(Expired)

Merck Sharp Dohme
Temodar US7786118 Pharmaceutical formulations of antineoplastic agents Feb 21, 2023

(Expired)

Merck Sharp Dohme
Temodar US8623868 Processes of making and using pharmaceutical formulations of antineoplastic agents Feb 21, 2023

(Expired)

Merck Sharp Dohme
Temodar US5260291

(Pediatric)

Tetrazine derivatives Feb 11, 2014

(Expired)

Merck Sharp Dohme
Temodar US5260291 Tetrazine derivatives Aug 11, 2013

(Expired)

Merck Sharp Dohme



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 Temozolomide's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 13 Jan, 2022 US7786118
Payment of Maintenance Fee, 8th Year, Large Entity 17 Jan, 2018 US7786118
Correspondence Address Change 26 Aug, 2011 US7786118
Correspondence Address Change 26 Aug, 2011 US6987108
Post Issue Communication - Certificate of Correction 09 Feb, 2011 US7786118
Recordation of Patent Grant Mailed 31 Aug, 2010 US7786118
Patent Issue Date Used in PTA Calculation 31 Aug, 2010 US7786118
Issue Notification Mailed 11 Aug, 2010 US7786118
Application Is Considered Ready for Issue 03 Aug, 2010 US7786118
Dispatch to FDC 03 Aug, 2010 US7786118


Temozolomide's Family Patents

Family Patents

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Temozolomide Generic API Manufacturers

Several generic applications have been filed for Temozolomide. The first generic version for Temozolomide was by Heritage Pharma Labs Inc Dba Avet Pharma Labs Inc and was approved on Mar 1, 2010. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Aug 23, 2024.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 6 different strengths of generic version for Temozolomide. 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
250MG

(reference standard)

capsule Prescription ORAL AB Feb 27, 2017
5MG

capsule Prescription ORAL AB Feb 27, 2017
20MG

capsule Prescription ORAL AB Feb 27, 2017
100MG

capsule Prescription ORAL AB Feb 27, 2017
140MG

capsule Prescription ORAL AB Feb 27, 2017
180MG

capsule Prescription ORAL AB Feb 27, 2017





2. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Prescription ORAL AB May 8, 2015
250MG

capsule Prescription ORAL AB May 8, 2015
180MG

capsule Prescription ORAL AB May 8, 2015
140MG

capsule Prescription ORAL AB May 8, 2015
100MG

capsule Prescription ORAL AB May 8, 2015
20MG

capsule Prescription ORAL AB May 8, 2015





3. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 6 different strengths of generic version for Temozolomide. 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
180MG

capsule Discontinued ORAL N/A Jul 13, 2016
5MG

capsule Discontinued ORAL N/A Jul 13, 2016
20MG

capsule Discontinued ORAL N/A Jul 13, 2016
100MG

capsule Discontinued ORAL N/A Jul 13, 2016
140MG

capsule Discontinued ORAL N/A Jul 13, 2016
250MG

capsule Discontinued ORAL N/A Jul 13, 2016





4. APOTEX

Apotex Inc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Apotex.

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

capsule Discontinued ORAL N/A Jul 5, 2018
250MG

capsule Discontinued ORAL N/A Jul 5, 2018
180MG

capsule Discontinued ORAL N/A Jul 5, 2018
140MG

capsule Discontinued ORAL N/A Jul 5, 2018
100MG

capsule Discontinued ORAL N/A Jul 5, 2018
5MG

capsule Discontinued ORAL N/A Jul 5, 2018


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





5. CHARTWELL

Chartwell Life Molecules Llc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Chartwell.

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

capsule Prescription ORAL AB Apr 12, 2016
5MG

capsule Prescription ORAL AB Apr 12, 2016
20MG

capsule Prescription ORAL AB Apr 12, 2016
140MG

capsule Prescription ORAL AB Apr 12, 2016
180MG

capsule Prescription ORAL AB Apr 12, 2016
250MG

capsule Prescription ORAL AB Apr 12, 2016


Manufacturing Plant Locations
New

Chartwell'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 Chartwell as present at those locations.

Country City Firm Name
United States
Carmel Chartwell Pharmaceuticals Carmel LLC
West Caldwell Chartwell Pharmaceuticals West Caldwell LLC
Congers Chartwell Life Sciences LLC
Congers Chartwell Pharmaceuticals LLC
Richboro Chartwells Division of Compass Group / Commodities Locker





6. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 6 different strengths of generic version for Temozolomide. 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
250MG

capsule Discontinued ORAL N/A Feb 10, 2016
5MG

capsule Discontinued ORAL N/A Feb 10, 2016
20MG

capsule Discontinued ORAL N/A Feb 10, 2016
100MG

capsule Discontinued ORAL N/A Feb 10, 2016
140MG

capsule Discontinued ORAL N/A Feb 10, 2016
180MG

capsule Discontinued ORAL N/A Feb 10, 2016





7. CHEMI SPA

Chemi Spa has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Chemi Spa.

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

capsule Prescription ORAL AB Nov 23, 2016
100MG

capsule Prescription ORAL AB Nov 23, 2016
140MG

capsule Prescription ORAL AB Nov 23, 2016
180MG

capsule Prescription ORAL AB Nov 23, 2016
250MG

capsule Prescription ORAL AB Nov 23, 2016
5MG

capsule Prescription ORAL AB Nov 23, 2016





8. DEVA HOLDING AS

Deva Holding As has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Deva Holding As.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Prescription ORAL AB Apr 26, 2017
20MG

capsule Prescription ORAL AB Apr 26, 2017
100MG

capsule Prescription ORAL AB Apr 26, 2017
140MG

capsule Prescription ORAL AB Apr 26, 2017
180MG

capsule Prescription ORAL AB Apr 26, 2017
250MG

capsule Prescription ORAL AB Apr 26, 2017





9. HERITAGE

Heritage Pharma Labs Inc Dba Avet Pharma Labs Inc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Heritage.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Discontinued ORAL N/A Mar 1, 2010
20MG

capsule Discontinued ORAL N/A Mar 1, 2010
100MG

capsule Discontinued ORAL N/A Mar 1, 2010
250MG

capsule Discontinued ORAL N/A Mar 1, 2010
140MG

capsule Discontinued ORAL N/A Mar 1, 2010
180MG

capsule Discontinued ORAL N/A Mar 1, 2010


Manufacturing Plant Locations
New

Heritage'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 Heritage as present at those locations.

Country City Firm Name
United States
Alger Heritage Cooperative
Dola Heritage Cooperative Inc
Chino Heritage #2
Upper Sandusky Heritage Cooperative
Middlebury Heritage Acres
Beloit Heritage Cooperative
South Burlington Heritage Aviation
London Heritage Cooperative, Inc
Caldwell Heritage Country Store-Heritage Cooperative
Richwood Heritage Cooperative, Inc
Kenton Heritage Cooperative
Vanlue Heritage Cooperative
London Heritage Cooperative Inc.
Springfield Heritage Cooperative, Inc
Van Nuys Heritage Candy Company, Inc.
De Graff Heritage Cooperative Inc
West Liberty Heritage Cooperative, Inc
West Mansfield Heritage Cooperative Inc.
Sacramento Heritage Baking Company Inc.
Woodsfield Heritage Cooperative
Waterford Heritage Cooperative
Urbana Heritage Cooperative Inc
Minneapolis Heritage Deli Provisions, LLC
Fletcher Heritage Cooperative Inc
Mc Cutchenville Heritage Cooperative, Inc
Plain City Heritage Cooperative Inc.
Morgantown Heritage Animal Hospital
Canfield Heritage Cooperative
New Philadelphia Heritage Cooperative
Cairo Heritage Cooperative
Lisbon Heritage Cooperative, Inc.
Ada Heritage Cooperative Inc
Fort Scott Heritage Acres Farm





10. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Prescription ORAL AB Aug 23, 2024
20MG

capsule Prescription ORAL AB Aug 23, 2024
100MG

capsule Prescription ORAL AB Aug 23, 2024
140MG

capsule Prescription ORAL AB Aug 23, 2024
180MG

capsule Prescription ORAL AB Aug 23, 2024
250MG

capsule Prescription ORAL AB Aug 23, 2024





11. LANNETT HOLDINGS INC

Lannett Holdings Inc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Lannett Holdings Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Prescription ORAL AB Mar 23, 2016
250MG

capsule Prescription ORAL AB Mar 23, 2016
180MG

capsule Prescription ORAL AB Mar 23, 2016
140MG

capsule Prescription ORAL AB Mar 23, 2016
100MG

capsule Prescription ORAL AB Mar 23, 2016
20MG

capsule Prescription ORAL AB Mar 23, 2016





12. NIVAGEN PHARMS INC

Nivagen Pharmaceuticals Inc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Nivagen Pharms Inc.

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

capsule Discontinued ORAL N/A Nov 23, 2021
5MG

capsule Discontinued ORAL N/A Nov 23, 2021
100MG

capsule Discontinued ORAL N/A Nov 23, 2021
250MG

capsule Discontinued ORAL N/A Nov 23, 2021
180MG

capsule Discontinued ORAL N/A Nov 23, 2021
140MG

capsule Discontinued ORAL N/A Nov 23, 2021





13. RISING

Rising Pharma Holdings Inc has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
180MG

capsule Discontinued ORAL N/A Jun 29, 2016
5MG

capsule Discontinued ORAL N/A Jun 29, 2016
20MG

capsule Discontinued ORAL N/A Jun 29, 2016
250MG

capsule Discontinued ORAL N/A Jun 29, 2016
100MG

capsule Discontinued ORAL N/A Jun 29, 2016
140MG

capsule Discontinued ORAL N/A Jun 29, 2016


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





14. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 6 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

capsule Prescription ORAL AB Feb 12, 2014
5MG

capsule Prescription ORAL AB Feb 12, 2014
20MG

capsule Prescription ORAL AB Feb 12, 2014
100MG

capsule Prescription ORAL AB Feb 12, 2014
140MG

capsule Prescription ORAL AB Feb 12, 2014
180MG

capsule Prescription ORAL AB Feb 12, 2014


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Vadodara Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Halol Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)





15. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Temozolomide. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

capsule Discontinued ORAL N/A Apr 18, 2017
20MG

capsule Discontinued ORAL N/A Apr 18, 2017
100MG

capsule Discontinued ORAL N/A Apr 18, 2017
140MG

capsule Discontinued ORAL N/A Apr 18, 2017
250MG

capsule Discontinued ORAL N/A Apr 18, 2017





16. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Temozolomide. 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
5MG

capsule Prescription ORAL AB Jul 31, 2017
20MG

capsule Prescription ORAL AB Jul 31, 2017
100MG

capsule Prescription ORAL AB Jul 31, 2017
140MG

capsule Prescription ORAL AB Jul 31, 2017
180MG

capsule Prescription ORAL AB Jul 31, 2017
250MG

capsule Prescription ORAL AB Jul 31, 2017