Everolimus Patent Expiration
Everolimus is used for treating advanced hormone receptor positive, HER2-negative breast cancer, progressive neuroendocrine tumors of pancreatic origin, tuberous sclerosis complex with subependymal giant cell astrocytoma, and solid excretory system tumors including advanced renal cell carcinoma. It was first introduced by Novartis Pharmaceuticals Corp
Everolimus Patents
Given below is the list of patents protecting Everolimus, 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 |
|---|---|---|---|---|
| Afinitor | US9006224 | Neuroendocrine tumor treatment | Jul 01, 2028 | Novartis |
| Afinitor |
US8410131 (Pediatric) | Cancer treatment | May 01, 2026 | Novartis |
| Afinitor | US8410131 | Cancer treatment | Nov 01, 2025 | Novartis |
| Afinitor Disperz |
US8617598 (Pediatric) | Pharmaceutical compositions comprising colloidal silicon dioxide |
Mar 27, 2023
(Expired) | Novartis Pharm |
| Afinitor Disperz | US8617598 | Pharmaceutical compositions comprising colloidal silicon dioxide |
Sep 27, 2022
(Expired) | Novartis Pharm |
| Afinitor |
US8436010 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug 22, 2022
(Expired) | Novartis |
| Afinitor |
US8778962 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug 18, 2022
(Expired) | Novartis |
| Afinitor Disperz |
US8778962 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug 18, 2022
(Expired) | Novartis Pharm |
| Afinitor | US8436010 | Treatment of solid tumors with rapamycin derivatives |
Feb 22, 2022
(Expired) | Novartis |
| Afinitor | US8778962 | Treatment of solid tumors with rapamycin derivatives |
Feb 18, 2022
(Expired) | Novartis |
| Afinitor Disperz | US8778962 | Treatment of solid tumors with rapamycin derivatives |
Feb 18, 2022
(Expired) | Novartis Pharm |
| Afinitor |
US7297703 (Pediatric) | Macrolides |
Jun 06, 2020
(Expired) | Novartis |
| Afinitor Disperz |
US7297703 (Pediatric) | Macrolides |
Jun 06, 2020
(Expired) | Novartis Pharm |
| Afinitor |
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar 09, 2020
(Expired) | Novartis |
| Afinitor Disperz |
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar 09, 2020
(Expired) | Novartis Pharm |
| Zortress |
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar 09, 2020
(Expired) | Novartis |
| Afinitor | US7297703 | Macrolides |
Dec 06, 2019
(Expired) | Novartis |
| Afinitor | US7741338 | Macrolides |
Dec 06, 2019
(Expired) | Novartis |
| Afinitor Disperz | US7297703 | Macrolides |
Dec 06, 2019
(Expired) | Novartis Pharm |
| Afinitor | US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep 09, 2019
(Expired) | Novartis |
| Afinitor Disperz | US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep 09, 2019
(Expired) | Novartis Pharm |
| Zortress | US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep 09, 2019
(Expired) | Novartis |
| Zortress |
US6239124 (Pediatric) | Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin |
Feb 11, 2018
(Expired) | Novartis |
| Zortress |
US6455518 (Pediatric) | Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin |
Jan 29, 2018
(Expired) | Novartis |
| Zortress | US6239124 | Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin |
Aug 11, 2017
(Expired) | Novartis |
| Zortress | US6455518 | Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin |
Jul 29, 2017
(Expired) | Novartis |
| Afinitor |
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan 12, 2017
(Expired) | Novartis |
| Afinitor Disperz |
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan 12, 2017
(Expired) | Novartis Pharm |
| Zortress |
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan 12, 2017
(Expired) | Novartis |
| Afinitor | US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul 12, 2016
(Expired) | Novartis |
| Afinitor Disperz | US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul 12, 2016
(Expired) | Novartis Pharm |
| Zortress | US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul 12, 2016
(Expired) | Novartis |
| Zortress |
US6440990 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar 24, 2014
(Expired) | Novartis |
| Zortress | US6440990 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep 24, 2013
(Expired) | Novartis |
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 Everolimus's patents.
Latest Legal Activities on Everolimus's Patents
Given below is the list recent legal activities going on the following patents of Everolimus.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 10 Nov, 2018 | US6455518(Litigated) |
| Post Issue Communication - Certificate of Correction | 10 Sep, 2018 | US6455518(Litigated) |
| Post Issue Communication - Certificate of Correction | 21 Jun, 2018 | US6455518(Litigated) |
| Post Issue Communication - Certificate of Correction | 14 May, 2018 | US6455518(Litigated) |
| Mail Certificate of Correction Memo | 18 Apr, 2018 | US6455518(Litigated) |
| Certificate of Correction Memo | 17 Apr, 2018 | US6455518(Litigated) |
| Request for Trial Denied Critical | 28 Apr, 2016 | US6455518(Litigated) |
| Petition Requesting Trial | 26 Oct, 2015 | US6455518(Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 24 Sep, 2002 | US6455518(Litigated) |
| Recordation of Patent Grant Mailed Critical | 24 Sep, 2002 | US6455518(Litigated) |
Everolimus's Family Patents
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Everolimus Generic API Manufacturers
Several generic applications have been filed for Everolimus. The first generic version for Everolimus was by Hikma Pharmaceuticals Usa Inc and was approved on Apr 12, 2018. And the latest generic version is by Biocon Pharma Ltd and was approved on Apr 9, 2025.
Given below is the list of companies who have filed for Everolimus generic, along with the locations of their manufacturing plants worldwide.
1. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 4 different strengths of generic version for Everolimus. 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 |
|---|---|---|---|---|---|
| 1MG | tablet | Prescription | ORAL | AB | Nov 26, 2021 |
| 0.75MG | tablet | Prescription | ORAL | AB | Nov 26, 2021 |
| 0.5MG | tablet | Prescription | ORAL | AB | Nov 26, 2021 |
| 0.25MG | tablet | Prescription | ORAL | AB | Nov 26, 2021 |
2. AMNEAL
Amneal Eu Ltd has filed for 3 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3MG | tablet, for suspension | Prescription | ORAL | AB | Jan 10, 2025 |
| 2MG | tablet, for suspension | Prescription | ORAL | AB | Jan 10, 2025 |
| 5MG | tablet, for suspension | Prescription | ORAL | AB | Jan 10, 2025 |
Manufacturing Plant Locations New
Amneal'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 Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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3. BIOCON PHARMA
Biocon Pharma Ltd has filed for 8 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Biocon Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 7.5MG | tablet | Prescription | ORAL | AB | Feb 11, 2021 |
| 10MG | tablet | Prescription | ORAL | AB | Feb 11, 2021 |
| 2.5MG | tablet | Prescription | ORAL | AB | Feb 11, 2021 |
| 5MG | tablet | Prescription | ORAL | AB | Feb 11, 2021 |
| 1MG | tablet | Prescription | ORAL | AB | Apr 9, 2025 |
| 0.25MG | tablet | Prescription | ORAL | AB | Apr 9, 2025 |
| 0.5MG | tablet | Prescription | ORAL | AB | Apr 9, 2025 |
| 0.75MG | tablet | Prescription | ORAL | AB | Apr 9, 2025 |
Manufacturing Plant Locations New
Biocon 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 Biocon Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
4. BRECKENRIDGE
Breckenridge Pharmaceutical Inc has filed for 7 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Breckenridge.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
| 10MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
| 2.5MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
| 7.5MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
| 0.5MG | tablet | Prescription | ORAL | AB | May 20, 2021 |
| 0.25MG | tablet | Prescription | ORAL | AB | May 20, 2021 |
| 0.75MG | tablet | Prescription | ORAL | AB | May 20, 2021 |
Manufacturing Plant Locations New
Breckenridge'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 Breckenridge as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
5. ENDO OPERATIONS
Endo Operations Ltd has filed for 8 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 7.5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 10MG | tablet | Prescription | ORAL | AB | Dec 9, 2020 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 18, 2021 |
| 0.25MG | tablet | Prescription | ORAL | AB | Oct 18, 2021 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 18, 2021 |
| 0.75MG | tablet | Prescription | ORAL | AB | Oct 18, 2021 |
6. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 8 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG | tablet | Prescription | ORAL | AB | Apr 12, 2018 |
| 0.25MG | tablet | Prescription | ORAL | AB | Apr 12, 2018 |
| 0.75MG | tablet | Prescription | ORAL | AB | Apr 12, 2018 |
| 2.5MG | tablet | Prescription | ORAL | AB | Jun 8, 2020 |
| 5MG | tablet | Prescription | ORAL | AB | Jun 8, 2020 |
| 7.5MG | tablet | Prescription | ORAL | AB | Jun 8, 2020 |
| 1MG | tablet | Prescription | ORAL | AB | Nov 18, 2021 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 23, 2021 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
| Portugal |
| |||||||||
| Jordan |
| |||||||||
7. MYLAN
Mylan Pharmaceuticals Inc has filed for 6 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2MG | tablet, for suspension | Prescription | ORAL | AB | Apr 19, 2019 |
| 3MG | tablet, for suspension | Prescription | ORAL | AB | Apr 19, 2019 |
| 5MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2020 |
| 10MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2020 |
| 7.5MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2020 |
| 2.5MG | tablet | Discontinued | ORAL | N/A | Jun 8, 2020 |
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 |
| |||||||||||||||||
| India |
| |||||||||||||||||
| Canada |
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| Ireland |
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8. NATCO
Natco Pharma Ltd has filed for 3 different strengths of generic version for Everolimus. Given below are the details of the strengths of this generic introduced by Natco.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet, for suspension | Prescription | ORAL | AB | Jan 28, 2025 |
| 2MG | tablet, for suspension | Prescription | ORAL | AB | Jan 28, 2025 |
| 3MG | tablet, for suspension | Prescription | ORAL | AB | Jan 28, 2025 |
Manufacturing Plant Locations New
Natco's manufacturing plants are situated in 2 countries - United Kingdom, India. Given below are the details of these plant locations as well as the firm names of Natco as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom |
| |||||||||||||
| India |
| |||||||||||||
9. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Everolimus. 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 |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 7.5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
| 2.5MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |