Sunitinib Malate Patent Expiration
Sunitinib Malate is Used for treating gastrointestinal stromal tumors and protein kinase related disorders, such as renal cell carcinoma and advanced pancreatic neuroendocrine tumors. It was first introduced by Cp Pharmaceuticals International Cv
Sunitinib Malate Patents
Given below is the list of patents protecting Sunitinib Malate, 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 |
|---|---|---|---|---|
| Sutent |
US6573293 (Pediatric) | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Aug 15, 2021
(Expired) | Cppi Cv |
| Sutent |
US7125905 (Pediatric) | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Aug 15, 2021
(Expired) | Cppi Cv |
| Sutent |
US7211600 (Pediatric) | Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds |
Jun 22, 2021
(Expired) | Cppi Cv |
| Sutent | US6573293 | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Feb 15, 2021
(Expired) | Cppi Cv |
| Sutent | US7125905 | Pyrrole substituted 2-indolinone protein kinase inhibitors |
Feb 15, 2021
(Expired) | Cppi Cv |
| Sutent | US7211600 | Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds |
Dec 22, 2020
(Expired) | Cppi Cv |
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 Sunitinib Malate's patents.
Latest Legal Activities on Sunitinib Malate's Patents
Given below is the list recent legal activities going on the following patents of Sunitinib Malate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Oct, 2018 | US7211600(Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Mar, 2018 | US7125905(Litigated) |
| Patent Term Extension Certificate Critical | 06 Apr, 2016 | US6573293(Litigated) |
| Patent Term Extension Certificate Critical | 17 Nov, 2015 | US6573293(Litigated) |
| Notice of Final Determination -Eligible | 16 Jun, 2015 | US6573293(Litigated) |
| Notice of Final Determination -Eligible | 23 Apr, 2015 | US6573293(Litigated) |
| FDA Final Eligibility Letter Critical | 21 Jan, 2015 | US6573293(Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 15 May, 2014 | US6573293(Litigated) |
| transaction for FDA Determination of Regulatory Review Period | 02 May, 2014 | US6573293(Litigated) |
| Second letter to regulating agency to determine regulatory review period | 05 Sep, 2013 | US6573293(Litigated) |
Sunitinib Malate's Family Patents
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Sunitinib Malate Generic API Manufacturers
Several generic applications have been filed for Sunitinib Malate. The first generic version for Sunitinib Malate was by Sun Pharmaceutical Industries Ltd and was approved on Aug 16, 2021. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Mar 14, 2024.
Given below is the list of companies who have filed for Sunitinib Malate generic, along with the locations of their manufacturing plants worldwide.
1. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Sunitinib Malate. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Apr 11, 2022 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Apr 11, 2022 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Apr 11, 2022 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Apr 11, 2022 |
2. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Sunitinib Malate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Mar 14, 2024 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Mar 14, 2024 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Mar 14, 2024 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Mar 14, 2024 |
Manufacturing Plant Locations New
Eugia Pharma'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 Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
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3. MYLAN
Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Sunitinib Malate. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Dec 6, 2021 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Dec 6, 2021 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Dec 6, 2021 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Dec 6, 2021 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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4. NATCO PHARMA
Natco Pharma Ltd has filed for 4 different strengths of generic version for Sunitinib Malate. Given below are the details of the strengths of this generic introduced by Natco Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Oct 24, 2023 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Oct 24, 2023 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Oct 24, 2023 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Oct 24, 2023 |
Manufacturing Plant Locations New
Natco Pharma'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 Natco Pharma as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||
5. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Sunitinib Malate. 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 |
|---|---|---|---|---|---|
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Aug 16, 2021 |
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Aug 16, 2021 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Aug 16, 2021 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Aug 16, 2021 |
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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6. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Sunitinib Malate. 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 |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Nov 30, 2021 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Nov 30, 2021 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Nov 30, 2021 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Nov 30, 2021 |
7. WANBANG BIOPHARMS
Wanbang Biopharmaceuticals has filed for 4 different strengths of generic version for Sunitinib Malate. Given below are the details of the strengths of this generic introduced by Wanbang Biopharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12.5MG BASE | capsule | Prescription | ORAL | AB | Aug 21, 2023 |
| EQ 25MG BASE | capsule | Prescription | ORAL | AB | Aug 21, 2023 |
| EQ 37.5MG BASE | capsule | Prescription | ORAL | AB | Aug 21, 2023 |
| EQ 50MG BASE | capsule | Prescription | ORAL | AB | Aug 21, 2023 |