Temozolomide Patent Expiration
Temozolomide is Used for treating malignant neoplasms. It was first introduced by Merck Sharp And Dohme Corp
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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 26 Aug, 2011 | US7786118 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6987108 |
| Post Issue Communication - Certificate of Correction | 09 Feb, 2011 | US7786118 |
| Recordation of Patent Grant Mailed Critical | 31 Aug, 2010 | US7786118 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Aug, 2010 | US7786118 |
| Issue Notification Mailed Critical | 11 Aug, 2010 | US7786118 |
| Application Is Considered Ready for Issue Critical | 03 Aug, 2010 | US7786118 |
| Dispatch to FDC | 03 Aug, 2010 | US7786118 |
Temozolomide's 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 |
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| Canada |
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| India |
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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 |
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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 |
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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 |
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| Mexico |
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| India |
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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 |
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| India |
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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 |