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 in its drug Afinitor on Mar 30, 2009. Other drugs containing Everolimus are Afinitor Disperz, Zortress. 9 different companies have introduced drugs containing Everolimus.


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.

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

Activity Date Patent Number
Patent litigations
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 28 Apr, 2016 US6455518(Litigated)
Petition Requesting Trial 26 Oct, 2015 US6455518(Litigated)
Patent Issue Date Used in PTA Calculation 24 Sep, 2002 US6455518(Litigated)
Recordation of Patent Grant Mailed 24 Sep, 2002 US6455518(Litigated)


Everolimus's Family Patents

Family Patents

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Everolimus Generics

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 Alkem Laboratories Ltd and was approved on Nov 26, 2021.

Given below is the list of companies who have filed for Everolimus generic.


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
0.75MG tablet Prescription ORAL AB Nov 26, 2021
1MG tablet Prescription ORAL AB Nov 26, 2021
0.25MG tablet Prescription ORAL AB Nov 26, 2021
0.5MG tablet Prescription ORAL AB Nov 26, 2021


2. BIOCON PHARMA

Biocon Pharma 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 Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Feb 11, 2021
7.5MG tablet Prescription ORAL AB Feb 11, 2021
2.5MG tablet Prescription ORAL AB Feb 11, 2021
5MG tablet Prescription ORAL AB Feb 11, 2021


3. 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
7.5MG tablet Prescription ORAL AB Mar 5, 2021
2.5MG tablet Prescription ORAL AB Mar 5, 2021
0.5MG tablet Prescription ORAL AB May 20, 2021
0.75MG tablet Prescription ORAL AB May 20, 2021
0.25MG tablet Prescription ORAL AB May 20, 2021


4. 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
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
10MG tablet Prescription ORAL AB Dec 9, 2020
0.75MG tablet Prescription ORAL AB Oct 18, 2021
0.25MG tablet Prescription ORAL AB Oct 18, 2021
1MG tablet Prescription ORAL AB Oct 18, 2021
0.5MG tablet Prescription ORAL AB Oct 18, 2021


5. 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
0.75MG tablet Prescription ORAL AB Apr 12, 2018
0.25MG tablet Prescription ORAL AB Apr 12, 2018
0.5MG 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


6. 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
5MG tablet Prescription ORAL AB Jun 8, 2020
3MG tablet, for suspension Prescription ORAL AB Apr 19, 2019
2.5MG tablet Prescription ORAL AB Jun 8, 2020
7.5MG tablet Prescription ORAL AB Jun 8, 2020
10MG tablet Prescription ORAL AB Jun 8, 2020


7. 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
2.5MG tablet Prescription ORAL AB Dec 9, 2019
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