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. Ten 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

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	021560-002	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	021560-003	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
Portugal	839028
Portugal	867438
Austria	272063
Spain	2182112
Hungary	224074	O-alkilezett rapamicinszármazékok, azokat tartalmazó gyógyszerkészítmények és eljárás a gyógyszerkészítmények előállítására (O-ALKYLATED RAPAMYCIN DERIVATIVES PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND PROCESS FOR PRODUCING THE PHARMACEUTICAL COMPOSITIONS)
Slovakia	4498	PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for ZORTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	91104	Luxembourg		91104, EXPIRES: 20180718
3342411	LUC00148	Luxembourg		PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830
3342411	122020000008	Germany		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20110824
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
2269604	122016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
0663916	SPC/GB10/003	United Kingdom		PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803