EVEROLIMUS - Generic Drug Details

What are the generic drug sources for everolimus and what is the scope of patent protection?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Hikma, Par Pharm, and Teva Pharms Usa, and is included in fourteen NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Everolimus has two hundred and twenty-nine patent family members in thirty-one countries.

There are twelve drug master file entries for everolimus. Nine suppliers are listed for this compound.

Summary for EVEROLIMUS

International Patents:	229
US Patents:	2
Tradenames:	4
Applicants:	9
NDAs:	14
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	773
Patent Applications:	7,705
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for EVEROLIMUS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVEROLIMUS
What excipients (inactive ingredients) are in EVEROLIMUS?	EVEROLIMUS excipients list
DailyMed Link:	EVEROLIMUS at DailyMed

See drug prices for EVEROLIMUS

Recent Clinical Trials for EVEROLIMUS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Nationwide Children's Hospital	Phase 2

See all EVEROLIMUS clinical trials

Pharmacology for EVEROLIMUS

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for EVEROLIMUS

Antineoplastic Agents

Immunosuppressive Agents

Paragraph IV (Patent) Challenges for EVEROLIMUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AFINITOR DISPERZ	Tablets for Oral Suspension	everolimus	2 mg, 3 mg and 5 mg	203985	1	2016-12-30
AFINITOR	Tablets	everolimus	2.5 mg, 5 mg, and 7.5 mg	022334	1	2014-12-10
AFINITOR	Tablets	everolimus	10 mg	022334	1	2014-06-18
ZORTRESS	Tablets	everolimus	0.25 mg, 0.5 mg, and 0.75 mg	021560	3	2013-09-30

US Patents and Regulatory Information for EVEROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocon Pharma	EVEROLIMUS	everolimus	TABLET;ORAL	214182-001	Feb 11, 2021	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No					Y
Par Pharm	EVEROLIMUS	everolimus	TABLET;ORAL	207934-001	Dec 9, 2019	AB	RX	No	No
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-001	Apr 19, 2019	AB	RX	No	No
Par Pharm	EVEROLIMUS	everolimus	TABLET;ORAL	205775-003	Oct 18, 2021	AB	RX	No	No
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	AB	RX	Yes	No
Alkem Labs Ltd	EVEROLIMUS	everolimus	TABLET;ORAL	214138-001	Nov 26, 2021	AB	RX	No	No

Expired US Patents for EVEROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012

EU/EMA Drug Approvals for EVEROLIMUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Afinitor	everolimus	EMEA/H/C/001038 Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.	Authorised	no	no	no	2009-08-02
Novartis Europharm Limited	Votubia	everolimus	EMEA/H/C/002311 Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.	Authorised	no	no	no	2011-09-02

International Patents for EVEROLIMUS

Country	Patent Number	Title	Estimated Expiration
Slovakia	288545
Norway	20082683
Poland	414997
Norway	20131546
Cyprus	1118316
Norway	20131545
Russian Federation	2013143306

Supplementary Protection Certificates for EVEROLIMUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269604	CA 2016 00060	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
0663916	04C0012	France		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
2269604	C02269604/01	Switzerland		PRODUCT NAME: EVEROLIMUS (40-O-(2-HYDROXYETHYL)-RAPAMYCIN); REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 59174 17.11.2009
0663916	C00663916/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
3342411	2020C/504	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
2269603	92880	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (AFINITOR); AUTHORISATION NUMBER AND DATE: EU/1/09/538/001,003,004 ET 006-010 - AFINITOR
0663916	C300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718