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. Eleven 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:	67
Patent Applications:	4,495
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	021560-002	Apr 20, 2010
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	021560-003	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	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
Slovakia	283572
Germany	69322282
Italy	1284871	COMPOSIZIONE FARMACEUTICA A BASE DI MACROLIDE IN DISPERSIONE SOLIDA
China	1080120
Brazil	9609537
European Patent Office	0956034	COMPOSITIONS PHARMACEUTIQUES UTILES DANS LE TRAITEMENT DE REJETS DE GREFFE, D'ETATS AUTO-IMMUNS OU INFLAMMATOIRES, COMPRENANT DE LA CYCLOSPORINE A ET DE LA 40-0-(2-HYDROXYETHYL)-RAPAMYCINE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF TRANSPLANT REJECTION, AUTOIMMUNE OR INFLAMMATORY CONDITIONS COMPRISING CYCLOSPORIN A AND 40-0-(2-HYDROXYETHYL)-RAPAMYCIN)
Israel	144684	PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION IN THE FORM OF A SOLID DISPERSION COMPRISING 33-EPI-CHLORO-33-DESOXY-ASCOMYCIN

Supplementary Protection Certificates for ZORTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269603	122015000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
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
0663916	SZ 14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
2269604	62/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
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
3351246	CA 2019 00056	Denmark		PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
2269604	122016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803

ZORTRESS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ZORTRESS

Introduction

ZORTRESS, known by its generic name everolimus, is a significant drug in the field of organ transplantation, particularly for preventing organ rejection. Developed by Novartis, it has made substantial impacts in both medical and financial spheres. Here, we delve into the market dynamics and financial trajectory of ZORTRESS.

Approval and Medical Significance

ZORTRESS was a landmark approval by the FDA, marking the first mTOR inhibitor approved to prevent organ rejection in adult liver transplant patients in the US. This approval was based on the largest liver transplant study to date, which compared ZORTRESS plus reduced-exposure tacrolimus to standard tacrolimus. The study showed comparable efficacy and improved renal function for patients on ZORTRESS[1].

Market Impact

The approval of ZORTRESS for liver transplantation expanded its market reach beyond kidney transplantation, where it was already established. This expansion is crucial as it addresses a broader patient population and enhances Novartis's position in the transplant field.

Competitive Landscape

In the transplant immunosuppression market, ZORTRESS competes with other immunosuppressive drugs like tacrolimus. However, its unique mechanism as an mTOR inhibitor and its ability to reduce the dosage of other immunosuppressants like tacrolimus give it a competitive edge. This differentiation helps in capturing a significant market share and maintaining patient and physician preference[1].

Financial Performance

Revenue Contribution

ZORTRESS contributes significantly to Novartis's revenue. In the financial reports, ZORTRESS is often bundled with other products under the pharmaceutical segment. For instance, in 2022, the drug's sales were part of the USD 80 million revenue stream from the division[2].

Quarterly and Annual Sales

While specific quarterly sales figures for ZORTRESS alone are not always detailed, the drug's performance is reflected in the overall pharmaceutical segment's growth. For example, in the third quarter of 2011, Novartis's pharmaceutical sales rose 12%, driven by strong global product growth, which would include contributions from ZORTRESS[3].

Geographic Performance

ZORTRESS's sales performance varies geographically. In regions like Europe and the US, where it has been approved for both kidney and liver transplantation, the drug sees strong sales. In emerging markets, such as China and India, Novartis's overall pharmaceutical sales have shown significant growth, which could also include contributions from ZORTRESS[3].

Financial Trajectory

Operating Income and Margins

Novartis's financial trajectory, including ZORTRESS, has been influenced by various factors such as product mix, geographic performance, and operational efficiencies. In 2022, Novartis reported an operating income margin of 15.4% of net sales, which was affected by higher restructuring costs but also benefited from productivity and savings from streamlined operations[2].

Core Operating Income

Core operating income, which excludes one-time charges and other non-core items, has been a key metric for Novartis. In the first quarter of 2022, core operating income increased by 21% in constant currencies, driven by a lower prior year comparison and normalized business dynamics post-COVID impacts. This growth reflects the stable performance of drugs like ZORTRESS[5].

Free Cash Flow

Free cash flow is another important financial metric. In the first quarter of 2022, Novartis reported a free cash flow of USD 0.9 billion, a decrease from the prior year mainly due to the loss of dividends from associated companies like Roche. However, this does not directly reflect the performance of ZORTRESS but indicates overall financial health[5].

Risk Management and REMS

Risk Evaluation and Mitigation Strategy (REMS)

ZORTRESS is associated with serious risks such as wound-healing complications, hyperlipidemia, proteinuria, graft thrombosis, and nephrotoxicity when co-administered with standard doses of cyclosporine. To manage these risks, Novartis has implemented a REMS program, which includes a Medication Guide to inform healthcare providers and patients about these serious risks[4].

Industry Expert Insights

David Epstein, Division Head of Novartis Pharmaceuticals, highlighted the significance of ZORTRESS's approval for liver transplantation, stating, "This second indication for ZORTRESS in just three years in the US follows the recent European approval, further underscoring Novartis' continued commitment to bringing much needed treatment options to the transplant community worldwide."[1]

Market Expansion and Future Prospects

Global Approvals

ZORTRESS has been approved under the trade name Certican® by European Health Authorities for use in adult liver transplant patients since 2012. This global approval trajectory indicates a strong potential for continued market expansion and revenue growth[1].

Pipeline and Innovation

Novartis's strong pipeline and innovation in the transplant field, along with the success of ZORTRESS, position the company for sustained growth. New approvals and indications for existing drugs contribute to the company's ability to meet patient needs and drive long-term growth[3].

Key Takeaways

• Approval and Medical Significance: ZORTRESS is the first mTOR inhibitor approved for preventing organ rejection in adult liver transplant patients in the US.
• Market Impact: The drug has expanded its market reach beyond kidney transplantation, enhancing Novartis's position in the transplant field.
• Financial Performance: ZORTRESS contributes to Novartis's revenue, with the pharmaceutical segment showing strong growth.
• Risk Management: A REMS program is in place to manage serious risks associated with ZORTRESS.
• Global Approvals and Future Prospects: Global approvals and a strong pipeline indicate potential for continued market expansion and revenue growth.

FAQs

What is ZORTRESS used for?

ZORTRESS (everolimus) is used to prevent organ rejection in adult liver and kidney transplant patients.

What makes ZORTRESS unique in the market?

ZORTRESS is the first mTOR inhibitor approved for preventing organ rejection in adult liver transplant patients in the US, offering a unique mechanism of action compared to other immunosuppressive drugs.

What are the serious risks associated with ZORTRESS?

ZORTRESS is associated with serious risks such as wound-healing complications, hyperlipidemia, proteinuria, graft thrombosis, and nephrotoxicity when co-administered with standard doses of cyclosporine.

How does ZORTRESS impact Novartis's financial performance?

ZORTRESS contributes to Novartis's revenue and operating income, particularly within the pharmaceutical segment, which has shown strong growth in recent years.

What is the REMS program for ZORTRESS?

The REMS program for ZORTRESS includes a Medication Guide to inform healthcare providers and patients about the serious risks associated with the drug.

Sources

1. Novartis Media Release: "Novartis drug Zortress® is first in over a decade approved by FDA to prevent organ rejection in adult liver transplant patients"[1].
2. Novartis Q4 2022 Condensed Financial Report: Supplementary data to the Consolidated Financial Statements[2].
3. FierceBiotech: "Novartis achieves strong third quarter financial performance and pipeline progress"[3].
4. FDA Summary Review: "ZORTRESS prescription"[4].
5. Novartis First Quarter 2022 Condensed Interim Financial Report: Financial performance and pipeline progress[5].