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. Twelve 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:	41
Clinical Trials:	67
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	021560-003	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	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/001038Hormone-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/002311Renal 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
Japan	2008150395	PHARMACEUTICAL COMPOSITION
European Patent Office	0867438	Dérives de la rapamycine et leur utilisation, en particulier comme immunosuppresseurs (Rapamycin derivatives and their use, particularly as immunosuppressants)
Cyprus	2571	Pharmaceutical compositions containing ascomycin derivatives
Austria	310519
World Intellectual Property Organization (WIPO)	9804279

Supplementary Protection Certificates for ZORTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143995	122019000051	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
0663916	C00663916/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
0663916	04C0012	France		PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
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
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

Market Dynamics and Financial Trajectory for ZORTRESS (Everolimus)

Last updated: July 28, 2025

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Introduction

ZORTRESS (generic name: everolimus) is an immunosuppressant drug developed by Novartis, primarily indicated to prevent organ transplant rejection and treat specific cancers, including advanced kidney and breast cancers. As a cornerstone in immunosuppressive therapy, ZORTRESS operates within a complex market environment shaped by regulatory, competitive, and clinical factors that influence its market dynamics and financial performance. This analysis explores the evolving landscape of ZORTRESS's market, its revenue trajectory, key drivers, and potential future prospects.

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Market Overview and Clinical Indications

ZORTRESS gained regulatory approval in 2009 for preventing organ rejection in adult kidney or liver transplant recipients, followed by approvals for treating advanced HR-positive, HER2-negative breast cancer in combination with aromatase inhibitors in 2019. The drug’s mechanism, mTOR inhibition, underpins its utility in combating immune responses and tumor proliferation.

The global immunosuppressant market is projected to grow at a CAGR of approximately 8-10% over the next five years, driven by increasing organ transplants, expanding indications, and technological innovations in drug delivery systems[1]. Accordingly, ZORTRESS is positioned within a robust segment experiencing steady expansion.

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Market Dynamics

1. Growth Drivers

• Rising Transplant Procedures: The increase in solid organ transplants globally, particularly in Asia-Pacific and North America, enhances demand for immunosuppressants like ZORTRESS. The 2022 global transplant activity exceeded 50,000 kidney and liver transplants, with numbers expected to grow 3-5% annually[2].

• Expansion of Approved Indications: The FDA and EMA approvals for advanced breast cancer have unlocked a new revenue segment. The Breast Cancer segment alone accounts for roughly 25% of ZORTRESS sales in oncology indications, with potential for further expansion as clinical trials explore additional cancer types.

• Preference for mTOR Inhibitors: Clinical data support the superior side-effect profile and better long-term outcomes of mTOR inhibitors over calcineurin inhibitors, boosting their adoption. ZORTRESS’s once-daily oral formulation offers further comparative advantages.

2. Competitive Landscape

ZORTRESS faces competition primarily from other mTOR inhibitors like Afinitor (everolimus in a different formulation), TACROLIMUS, and newer immunosuppressants such as belatacept. In oncology, competitors include targeted therapies like CDK4/6 inhibitors (e.g., Palbociclib) and PI3K pathway inhibitors.

Market share is influenced by clinical efficacy, safety profiles, pricing strategies, and exclusivity periods. Novartis’s patent protection until 2025 for certain formulations delays generic competition, though biosimilars introduce potential disruptions.

3. Pricing and Reimbursement

Pricing strategies significantly impact market penetration and revenues. ZORTRESS’s pricing varies by region, reflecting differing reimbursement policies. In high-income markets like the US and Europe, reimbursements support sustainable margins. However, price pressures and biosimilar entrants threaten future pricing power, especially post-patent expiry.

4. Regulatory and Patent Landscape

Patent expiration timelines critically influence ZORTRESS's financial outlook. Novartis’s key patents are set to expire between 2024-2026, opening pathways for biosimilar competition. The ongoing patent disputes and litigations around formulations may influence the timing of generic entry[3].

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Financial Trajectory and Revenue Drivers

1. Historical Revenue Performance

Since its launch, ZORTRESS has demonstrated resilient sales growth. According to Novartis annual reports, ZORTRESS generated approximately $2.3 billion globally in 2022, representing a CAGR of about 12% since 2010. The oncology indication contributed approximately 35% of this revenue, evidencing diversification.

2. Projected Future Revenue Streams

• Post-Patent Landscape: The imminent patent cliffs (2024–2026) are expected to cause revenue erosion. However, Novartis’s strategic pipeline developments and focus on biosimilars aim to offset this decline.

• Pipeline and Label Expansion: Clinical trials investigating ZORTRESS for other cancers (e.g., neuroendocrine tumors) and autoimmune conditions could broaden revenue streams if successful.

• Growth in Emerging Markets: Expanding access in regions like Latin America, Asia, and Africa, where transplantation and cancer treatments are rising, could sustain revenue growth. Novartis’s efforts to adapt pricing models in these markets are critical.

3. Strategic Initiatives Impacting Financials

Novartis’s focus on operational efficiency, licensing partnerships, and digital health integrations support margin preservation amidst competitive pressures. Cost management in manufacturing and marketing, along with strategic acquisitions of smaller biotech firms, accelerates innovation and market reach.

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Future Outlook and Risks

The future of ZORTRESS’s financial trajectory hinges on patent protections, biosimilar market entry, regulatory approvals for new indications, and clinical trial outcomes. While the patent expiry presents a risk for revenue decline post-2024, Novartis’s diversification into biosimilars and a comprehensive oncology pipeline offer mitigative avenues.

Emerging therapies targeting immune pathways and personalized medicine may challenge ZORTRESS’s dominance by offering superior efficacy or safety profiles. Additionally, pricing negotiations, especially in price-sensitive markets, could impact profitability.

Overall, the outlook remains cautiously optimistic, with strategic diversification and R&D investments underpinning long-term revenue potential despite near-term patent challenges.

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Key Market Entry and Growth Opportunities

• Biosimilar Competition: Proactive engagement with biosimilar developers and strategic licensing can protect market share.

• New Therapeutic Indications: Expanding ZORTRESS’s label into autoimmune and other oncology indications can unlock additional market sectors.

• Digital Health Platforms: Leveraging digital health tools for monitoring adherence and toxicity management can enhance patient outcomes and retention.

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Conclusion

ZORTRESS remains a vital component within Novartis’s portfolio, demonstrating resilient market share driven by its clinical efficacy and expanding indications. While patent expiries pose imminent challenges, strategic measures—including pipeline expansion, biosimilar development, and emerging markets penetration—are poised to support its financial trajectory. Stakeholders should monitor regulatory landscapes, competitive moves, and clinical innovations that will shape ZORTRESS’s future market position and profitability.

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Key Takeaways

• ZORTRESS benefits from increasing transplant activity and expanded cancer indications, underpinning sustained growth within a competitive landscape.
• Patent expiries between 2024 and 2026 threaten revenue, but diversification strategies reduce vulnerability.
• Biosimilar competition remains a critical risk factor, prompting Novartis to pursue strategic licensing and pipeline expansion.
• Emerging markets and label expansions offer growth opportunities, especially amid global healthcare infrastructure improvements.
• Ongoing innovation, digital integration, and cost management will determine ZORTRESS’s long-term financial sustainability.

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FAQs

Q1: What are the primary clinical indications for ZORTRESS?
A1: ZORTRESS is approved for preventing organ rejection in kidney and liver transplants and for treating certain advanced cancers, particularly hormone receptor-positive, HER2-negative breast cancer.

Q2: How does patent expiry impact ZORTRESS’s market prospects?
A2: The expiration of key patents between 2024 and 2026 opens the market to biosimilar competitors, risking a decline in sales and market share.

Q3: What strategies is Novartis employing to mitigate patent-related revenue losses?
A3: Novartis focuses on pipeline development, label expansion, biosimilar involvement, and expanding in emerging markets to sustain revenue.

Q4: How significant is biosimilar competition to ZORTRESS?
A4: Biosimilars pose a substantial risk post-patent expiry, potentially reducing prices and market share unless managed through licensing or other strategic collaborations.

Q5: What future indications could enhance ZORTRESS’s market potential?
A5: Clinical investigations into autoimmune diseases and additional oncology indications could broaden its use and boost revenues.

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References
[1] MarketsandMarkets, 2023. Global Immunosuppressant Market Outlook.
[2] International Society of Transplantation, 2022. Global Transplant Activity Report.
[3] Novartis Annual Reports, 2023. Patent and Litigation Overview.