Everolimus - Generic Drug Details

What are the generic sources for everolimus and what is the scope of freedom to operate?

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 five 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 seventy-seven patent family members in thirty-eight countries.

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

Summary for everolimus

International Patents:	277
US Patents:	5
Tradenames:	4
Applicants:	9
NDAs:	14
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	773
Patent Applications:	7,099
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
Nationwide Children's Hospital	Phase 2
University of Miami	Phase 2
University of Wisconsin, Madison	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 P-Glycoprotein Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for everolimus

Antineoplastic Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for everolimus

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating 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
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No					Y
Alkem Labs Ltd	EVEROLIMUS	everolimus	TABLET;ORAL	214138-003	Nov 26, 2021	AB	RX	No	No
Breckenridge	EVEROLIMUS	everolimus	TABLET;ORAL	205432-001	May 20, 2021	AB	RX	No	No
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-002	Apr 19, 2019	AB	RX	No	No
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-003	Apr 19, 2019	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes					Y
Breckenridge	EVEROLIMUS	everolimus	TABLET;ORAL	205426-002	Mar 5, 2021	AB	RX	No	No

Expired US Patents for everolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010

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	yes	2011-09-02

International Patents for everolimus

Country	Patent Number	Title	Estimated Expiration
Morocco	29966	TRAITEMENT DES TUMEURS NEUROENDOCRINES
Norway	20190290
Denmark	2269603
Japan	2009516671
European Patent Office	1954269	TRAITEMENT DES TUMEURS NEUROENDOCRINES (NEUROENDOCRINE TUMOR TREATMENT USING MTOR INHIBITORS)
Denmark	3351246
Israel	191475	שימוש ב- 40-o-(2-hydroxyethyl)-rapamycin להכנת תרופה לטיפול בגידולים נוירואנדוקריניים בלבלב (Use of 40-o-(2-hydroxyethyl)-rapamycin for the manufacture of a medicament for the treatment of pancreatic neuroendocrine tumors)

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143995	34/2019	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2016) 3286 (MITTEILUNG) 20160530
2269604	132016000127697	Italy		PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/538/001-006, 20090805
3342411	PA2020503	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538 20110824
2269603	CA 2015 00058	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
2269603	300769	Netherlands		PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725
2269604	93320	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
3342411	301032	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE