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. 15 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.

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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

(Expired)

Novartis
Afinitor US8410131 Cancer treatment Nov 01, 2025

(Expired)

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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Clinical Trials

Recent Clinical Trials on Everolimus:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Treg Modulation With CD28 and IL-6 Receptor Antagonists National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Everolimus Aging Study University of Wisconsin, Madison NA COMPLETED
(Sep 1, 2026)
PHASE2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 1, 2026)
PHASE2
Dalpiciclib Plus Toremifene for First-line Advanced HR Positive and HER2 Negative Breast Cancer Tianjin Medical University Cancer Institute and Hospital NA RECRUITING
(Sep 1, 2026)
PHASE2
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors Exelixis NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment RTOG Foundation, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer M.D. Anderson Cancer Center NA COMPLETED
(Aug 1, 2026)
PHASE1
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021) University of California, San Francisco NA RECRUITING
(Aug 1, 2026)
PHASE1
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 Gustave Roussy, Cancer Campus, Grand Paris NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment Pfizer NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) Jiangsu Simcere Pharmaceutical Co., Ltd. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants Northwestern University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Breakthrough - T1DM and Chronic Kidney Disease University of Chicago NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC Fudan University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Evaluating the Combination of Everolimus and Sorafenib in the Treatment of Thyroid Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma M.D. Anderson Cancer Center NA COMPLETED
(Jul 1, 2026)
PHASE2
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy UNICANCER NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment Centre Leon Berard NA RECRUITING
(Jul 1, 2026)
PHASE2
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients ITM Solucin GmbH NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation M.D. Anderson Cancer Center NA TERMINATED
(Jul 1, 2026)
PHASE1
Itacitinib + Everolimus in Hodgkin Lymphoma University of Pennsylvania NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial Central Hospital, Nancy, France NA RECRUITING
(Jun 1, 2026)
PHASE2
177Lu-DOTATATE for Recurrent Meningioma European Organisation for Research and Treatment of Cancer - EORTC NA RECRUITING
(Jun 1, 2026)
PHASE2
MTOR Inhibitors in Older Adults University of Texas Southwestern Medical Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer Jonsson Comprehensive Cancer Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Fox Chase Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial National Cancer Institute (NCI) NA RECRUITING
(May 1, 2026)
PHASE2
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy iVascular S.L.U. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. Pfizer NA RECRUITING
(May 1, 2026)
PHASE3
EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Yonsei University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score Boston Children's Hospital NA COMPLETED
(Apr 1, 2026)
PHASE3
Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT Mats Remberger NA TERMINATED
(Apr 1, 2026)
PHASE2
Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors National Cancer Institute (NCI) NA RECRUITING
(Apr 1, 2026)
PHASE2
FUSCC Refractory TNBC Platform Study (FUTURE2.0) Fudan University NA RECRUITING
(Apr 1, 2026)
PHASE2
REgulatory T Cell Therapy to Achieve Immunosuppression REduction Singulera Therapeutics Inc. NA RECRUITING
(Apr 1, 2026)
PHASE2
Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women Odense University Hospital NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
EVR and EPO for Liver Transplant Tolerance National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Apr 1, 2026)
PHASE1
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors CSPC ZhongQi Pharmaceutical Technology Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL Philippe ROUSSELOT NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Phase I/II Trial of Everolimus in Combination With Lonafarnib in Progeria Boston Children's Hospital NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE1, PHASE2


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 I3 Pharmaceuticals Llc and was approved on Jun 30, 2026.

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


Everolimus News

Abbott launches its latest drug-eluting stent, the XIENCE Skypoint™, in India.

13 Mar, 2026

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