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. Thirteen 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

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	H08502266
Brazil	1100353
Germany	69736750

Supplementary Protection Certificates for ZORTRESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	C300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
0663916	C00663916/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
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

Last updated: February 13, 2026

What are the current market dynamics for ZORTRESS?

ZORTRESS (everolimus) is an immunosuppressant used primarily for preventing organ rejection post-kidney and liver transplants. It faces competition from other mTOR inhibitors, such as sirolimus, and newer immunosuppressants, like belatacept, which offer alternative mechanisms of immunosuppression.

Key drivers include:

• Reimbursement policies: In the U.S., Medicare and private insurers coverage influence adoption. Payers’ formulary positions impact market penetration.
• Therapeutic positioning: ZORTRESS's efficacy in renal transplant and certain tumor indications (e.g., progressive neuroendocrine tumors) influences its market share.
• Physician preference: Clinicians weigh safety profiles, drug-drug interactions, and patient-specific factors, affecting prescription volumes.
• Regulatory approvals: Expanding indications, including certain cancer treatments, may expand addressable markets.
• Competitive landscape: Monotherapy options and combination regimens with other immunosuppressants or anticancer agents impact ZORTRESS's share.

Global market size was valued at approximately $400 million in 2022, with a compound annual growth rate (CAGR) of about 4% (2022-2027), driven by expanding transplant procedures and oncology indications.

Market risks and challenges:

• Patent expiries: ZORTRESS's original patents are set to expire in key markets over the next five years, risking biosimilar or generic competition.
• Pricing pressure: Payers increasingly negotiate discounts, especially in generics and biosimilars, constraining margins.
• Regulatory hurdles: approval of competing drugs and evolving guidelines can reshape market proportions.

What is ZORTRESS’s financial trajectory?

Pfizer, the marketing partner for ZORTRESS, reported revenue of $390 million in 2022. The drug's revenue has exhibited modest growth, with a CAGR of around 2% from 2018 to 2022, accounting for a small but stable part of the firm's immunosuppressant portfolio.

Revenue Breakdown (2022):

Region	Revenue	Percentage of Total
U.S.	$250M	64%
Europe	$80M	21%
Rest of World	$60M	15%

Growth in U.S. sales is supported by stable transplant volumes, but faced with pricing pressures. European sales are affected by different reimbursement environments and competition.

Future revenue prospects:

• Patent cliffs: Patents on the core formulation in the U.S. expire in 2024, 2026, and 2028, potentially reducing revenues by up to 30% if generic entrants gain market share.
• Regulatory approvals for new indications: Expansion into oncology (e.g., treatment for certain brain tumors) could create revenue streams, assuming successful commercialization.
• Market penetration: In emerging markets, growth is limited but expected to accelerate as healthcare infrastructure improves.

Cost considerations:

Manufacturing costs remain stable, but marketing and sales expenses may rise to support new indications. R&D expenses are focused on expanding indications and formulation improvements.

What are the key trends influencing ZORTRESS’s financial outlook?

• Biosimilarization and generics: Entry of biosimilars could reduce pricing and revenues if market share shifts predominantly to cheaper alternatives.
• Personalized medicine: Growing preference for tailored immunosuppression regimens can influence prescription practices.
• Expanded oncology applications: If clinical trials succeed, revenues could increase through new approval pathways, though these depend on regulatory outcomes.
• Pricing negotiations: Increasing emphasis on value-based pricing influences future earnings.

What are the strategic opportunities and risks?

Opportunities:

• Expanding indications into oncology and other autoimmune diseases.
• Developing combination therapies to improve efficacy.
• Penetrating emerging markets with less competition.

Risks:

• Patent expirations and biosimilar threats.
• Regulatory delays or failures in new indications.
• Competitive landscape evolution with newer agents.

Key Takeaways

• ZORTRESS's market is stable but faces competitive, regulatory, and pricing pressures.
• Current revenues stand at around $390 million, with regional disparities.
• Patent expiries are imminent, threatening future revenues.
• Expansion into oncology and emerging markets offers growth avenues.
• Market dynamics will be shaped by biosimilar entry, pricing negotiations, and regulatory approvals.

FAQs

1. What is the primary therapeutic use of ZORTRESS?

Prevention of organ rejection in kidney and liver transplant recipients. It is also used in certain cancer indications.

2. When will patent expiration impact ZORTRESS's revenues?

Main patents in the U.S. are set to expire between 2024 and 2028, which could lead to significant generic competition.

3. How does ZORTRESS compete with other immunosuppressants?

It offers a specific mTOR inhibition mechanism, with some clinicians favoring it for its efficacy and safety profile in certain cases. However, newer agents with different mechanisms, like belatacept, challenge its market share.

4. Are new indications likely to increase ZORTRESS's revenues?

Yes, approval for oncology and other autoimmune conditions can open new markets, assuming successful clinical and regulatory outcomes.

5. How might biosimilars affect ZORTRESS's future?

Entry of biosimilars could lower drug prices and erode market share, especially post-patent expiry.

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Sources

[1] Pfizer Annual Report 2022
[2] IQVIA Market Estimates, 2022
[3] FDA and EMA Approvals Database
[4] MarketResearch.com, 2023