ZORTRESS Drug Patent Profile

When do Zortress patents expire, and when can generic versions of Zortress launch?

Zortress is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zortress

A generic version of ZORTRESS was approved as everolimus by HIKMA on April 12^th, 2018.

Summary for ZORTRESS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	66
Patent Applications:	4,495
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZORTRESS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZORTRESS
What excipients (inactive ingredients) are in ZORTRESS?	ZORTRESS excipients list
DailyMed Link:	ZORTRESS at DailyMed

See drug prices for ZORTRESS

Recent Clinical Trials for ZORTRESS

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

Sponsor	Phase
Johns Hopkins University	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
University of Cincinnati	Phase 4

See all ZORTRESS clinical trials

Pharmacology for ZORTRESS

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

Anatomical Therapeutic Chemical (ATC) Classes for ZORTRESS

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

L04AH	Mammalian target of rapamycin (mTOR) kinase inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ZORTRESS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORTRESS	Tablets	everolimus	0.25 mg, 0.5 mg, and 0.75 mg	021560	3	2013-09-30

US Patents and Regulatory Information for ZORTRESS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010	AB	RX	Yes	No
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-004	Aug 10, 2018	AB	RX	Yes	Yes
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010	AB	RX	Yes	No
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	AB	RX	Yes	No

Expired US Patents for ZORTRESS

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	021560-001	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010

EU/EMA Drug Approvals for ZORTRESS

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 ZORTRESS

See the table below for patents covering ZORTRESS around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1023720
Finland	951678
Hungary	T71232
Luxembourg	91104
Russian Federation	2159107	PHARMACEUTICAL COMPOSITIONS
European Patent Office	1208847	COMPOSITIONS PHARMACEUTIQUES DESTINEES AU TRAITEMENT DES ETATS DE REJET DE GREFFE AINSI QUE DES MALADIES AUTOIMMUNES OU INFLAMMATOIRES (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF TRANSPLANT REJECTION, AS WELL AS AUTOIMMUNE OR INFLAMMATORY CONDITIONS)

Supplementary Protection Certificates for ZORTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3351246	122019000102	Germany		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
3143995	C03143995/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016
0663916	14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN); NAT. REGISTRATION NO/DATE: 1-25271;1-25272; 1-25275,1-25276. 20040302; FIRST REGISTRATION: SE 18690;18691;18692; 18693;18694;18695. 20030718
0663916	2010/001	Ireland		PRODUCT NAME: EVEROLIMUS; NAT REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803; FIRST REGISTRATION NO/DATE: 18960 018691 18962 18693 18694 18695. 20030718
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
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