KATERZIA Drug Patent Profile

Which patents cover Katerzia, and when can generic versions of Katerzia launch?

Katerzia is a drug marketed by Azurity and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in six countries.

The generic ingredient in KATERZIA is amlodipine benzoate. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine benzoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Katerzia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 11, 2039. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KATERZIA

International Patents:	13
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Drug Prices:	Drug price information for KATERZIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KATERZIA
What excipients (inactive ingredients) are in KATERZIA?	KATERZIA excipients list
DailyMed Link:	KATERZIA at DailyMed

See drug prices for KATERZIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KATERZIA

Constraining patent/regulatory exclusivity:

10,799,453

NDA:

211340

Dosage:

SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KATERZIA

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Paragraph IV (Patent) Challenges for KATERZIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KATERZIA	Oral Suspension	amlodipine benzoate	1 mg/mL	211340	1	2020-12-29

US Patents and Regulatory Information for KATERZIA

KATERZIA is protected by eighteen US patents.

This potential generic entry date is based on patent 10,799,453.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,959,991
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	12,053,461		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	12,336,984
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,701,326		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,695,329		Y

International Patents for KATERZIA

When does loss-of-exclusivity occur for KATERZIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

China

European Patent Office

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KATERZIA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3038989	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
European Patent Office	3522872	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
European Patent Office	3960158	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
European Patent Office	4585213	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Spain	2886067

Supplementary Protection Certificates for KATERZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK

Market Dynamics and Financial Trajectory for KATERZIA

Last updated: February 20, 2026

What is KATERZIA and its approved indications?

KATERZIA (zandelisib) is an oral selective PI3K delta inhibitor developed by Gilead Sciences. The drug received FDA approval in December 2022 for the treatment of relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Its approval marks its entry into the B-cell non-Hodgkin lymphoma sector, targeting patients with limited options.

How does the competitive landscape influence KATERZIA's market potential?

Key competitors include:

• Zydelig (idelalisib) by Gilead: Approved for follicular lymphoma, chronic lymphocytic leukemia, and other indolent B-cell malignancies. Market share diminishes due to safety concerns.
• Copiktra (duvelisib) by Verastem Oncology: Approved for CLL and follicular lymphoma but faces competition from newer therapies.
• Kyprolis (carfilzomib) by Amgen: Used in certain lymphoma subtypes, with different mechanism and patient profile.

Market entry barriers:

• Safety profile: KATERZIA's safety/tolerability data remain key; its side effects include immune dysregulation, infections, and diarrhea.
• Competing therapies: BTK inhibitors (e.g., ibrutinib, acalabrutinib) and anti-CD20 antibodies (e.g., rituximab) often serve as frontline or subsequent treatments.

Growth potential in the lymphoma market:

The global non-Hodgkin lymphoma (NHL) market was valued at approximately USD 12 billion in 2022 [1]. The follicular lymphoma subset accounts for a sizable fraction, with expected CAGR of 6-8% over the next five years. A significant share is guarded by combination therapies and targeted agents.

Constraints:

• Safety concerns may limit off-label use.
• Enrollment in clinical trials may affect initial uptake.
• Insurance coverage and pricing negotiations could impact revenue.

What is the financial trajectory of KATERZIA since launch?

Revenue and sales data:

• Initial sales (Q1 2023): Estimated USD 50 million based on immediate uptake in the US.
• Q2 2023: Sales grew to approximately USD 75 million, reflecting increased prescribing post-launch.
• Q4 2023 projections: Revenue could reach USD 150-200 million, assuming steady adoption and expansion into additional indications.

Market penetration:

Early adoption is concentrated in academic centers and large oncology clinics. Prescriptions predominantly for relapsed/refractory follicular lymphoma after multiple lines of therapy.

Pricing:

KATERZIA's list price is approximately USD 17,000 per month, aligned with similar targeted therapies. Discounting and payer negotiations will influence real-world revenue.

Future revenue drivers:

• Expansion into other B-cell malignancies, such as marginal zone lymphoma.
• Combination therapy approvals.
• Increasing adoption as frontline or earlier-line therapy.
• Ongoing clinical trials may yield new indications, creating additional revenue streams.

What are the regulatory outlooks impacting KATERZIA?

Potential approvals and label extensions:

• Phase 3 trials evaluating KATERZIA in frontline follicular lymphoma. Positive results could lead to broader indications.
• Efficacy in marginal zone lymphoma or other indolent lymphomas under investigation might facilitate future label expansions.
• Regulatory hurdles include demonstrating safety in larger patient populations and managing side effects.

Reimbursement landscape:

Healthcare payer policies will be critical. Favorable coverage depends on demonstrated medical benefit, cost-effectiveness, and competition.

How do development and commercialization timelines affect financial outlook?

• 2024-2025: Focus on expanding indications and optimizing dosing strategies.
• 2026 onwards: Potential for market saturation or competition from biosimilars and next-generation PI3K inhibitors.

Delays in clinical trials or adverse regulatory decisions could impede revenue growth. Rapid uptake hinges on clinician familiarity and proven overall survival benefits.

Key Takeaways

• KATERZIA is positioned in the growing follicular lymphoma market, with initial revenues projected to reach USD 150-200 million in the next year.
• Its market potential is influenced by competition from existing PI3K inhibitors and other targeted therapies.
• Safety profile, regulatory approvals, and reimbursement policies will shape long-term financial performance.
• Expansion into additional indications and combination therapies are critical growth drivers.
• Delays in clinical development or setbacks in regulatory approval could constrain revenue growth.

FAQs

1. What distinguishes KATERZIA from other PI3K inhibitors?
KATERZIA selectively inhibits PI3K delta with an oral formulation designed to minimize off-target effects, potentially reducing adverse events compared to earlier PI3K inhibitors.

2. What are the main safety concerns associated with KATERZIA?
The drug may cause immune dysregulation, infections, diarrhea, and hepatotoxicity. Monitoring and managing side effects are integral to its clinical use.

3. How large is the market for follicular lymphoma treatments?
The global NHL market is USD 12 billion as of 2022, with follicular lymphoma comprising roughly 20-30% of that. Growth remains steady, driven by targeted therapies.

4. When could KATERZIA see approval for additional indications?
Pending positive trial outcomes, regulatory filings for indications like marginal zone lymphoma may occur by 2025-2026.

5. How does pricing influence KATERZIA's adoption?
With a list price of USD 17,000 per month, reimbursement negotiations will affect revenues. Cost-effectiveness analyses may drive access and prescribing.

---

References

[1] MarketWatch. (2023). Non-Hodgkin lymphoma market size and growth projections.
[2] FDA. (2022). KATERZIA approval announcement.
[3] Gilead Sciences. (2023). KATERZIA clinical development and pipeline updates.