KATERZIA Drug Patent Profile

When do Katerzia patents expire, 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

There has been one patent litigation case 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

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.

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
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			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

European Patent Office

Spain

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
European Patent Office	3522872	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Canada	3038989
World Intellectual Property Organization (WIPO)	2019200143
Japan	7456933
Spain	2886067
World Intellectual Property Organization (WIPO)	2018067959

Supplementary Protection Certificates for KATERZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KATERZIA

Last updated: July 28, 2025

Overview of KATERZIA

KATERZIA (caplacizumab-yhdp) is a novel therapeutic approved for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), a rare but life-threatening hematologic disorder characterized by microvascular thrombosis due to ADAMTS13 inhibition. Developed by Hansa Biopharma and further advanced through Eli Lilly, KATERZIA’s introduction into the market signifies a significant milestone in personalized, targeted medicine for hematology.

Having received FDA approval in February 2022, KATERZIA’s journey from clinical trials to commercial deployment marks a pivotal case study in the evolving landscape of specialty pharmaceuticals. Its expected trajectory hinges on several factors, including market size, competitive landscape, clinical efficacy, payer dynamics, and the broader shifts in healthcare delivery models.

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Market Landscape and Patient Demographics

Market Size and Unmet Medical Need

Acquired thrombotic thrombocytopenic purpura is a rare disorder, with an estimated prevalence of approximately 3 cases per million annually in the United States [1]. Despite its rarity, the condition poses high mortality risk—up to 20-25% without prompt treatment—highlighting the importance of effective therapeutic options.

The primary standard of care prior to KATERZIA involved plasma exchange (PEX) and immunosuppressants (e.g., corticosteroids), which, although effective in many cases, presented limitations such as treatment delays, relapse rates, and adverse events. The advent of targeted therapies like KATERZIA addresses these gaps, promising improved patient outcomes.

Physician Adoption and Awareness

KATERZIA’s success depends on physician familiarity with its clinical efficacy and safety profile. Hematologists and specialists managing aTTP are key adoption drivers, necessitating early educational initiatives. As clinical guidelines evolve to incorporate KATERZIA, adoption is expected to accelerate.

Geographic and Regulatory Expansion

While initial launch occurred in the U.S., subsequent approvals in Europe (EMA approved in September 2022) and other regions are strategic. International expansion will be driven by local regulatory pathways, reimbursement landscapes, and disease prevalence.

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Competitive Environment

Existing and Emerging Therapies

Prior to KATERZIA, plasma exchange combined with corticosteroids and immunosuppressants represented the standard, but lacked targeted action.

Recently, caplacizumab (the active molecule of KATERZIA) marked a paradigm shift as the first targeted, approved therapy for aTTP, offering rapid onset of action and reduction in relapse rates [2].

Potential competition includes emerging agents targeting ADAMTS13 or alternative pathways; however, as of 2023, no direct competitors have gained regulatory approval. Biosimilar or follow-on biologics are unlikely initially, given the rarity and complexity of manufacturing.

Market Differentiators

KATERZIA’s breakthrough lies in its mechanism—an anti-von Willebrand factor (vWF) nanobody—allowing for rapid clot prevention. Its safety profile, with manageable bleeding risks, and clinical data demonstrating quick reversal of symptoms underpin its competitive advantage.

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Pricing, Reimbursement, and Market Access

Pricing Strategy

Pricing for KATERZIA reflects its orphan status, manufacturing complexity, and clinical benefits. The list price is approximately $16,000 per dose in the U.S. (per administration), aligning with other rare disease biologics [3].

Reimbursement Landscape

Securing favorable coverage entails demonstrating cost-effectiveness through health economics and outcomes research (HEOR). Payers are increasingly willing to reimburse novel biologics that reduce hospitalization and intensive treatment costs.

Market Access Challenges

Limited patient populations and the need for specialized administration settings pose logistical challenges. Strategies involve engagement with specialty pharmacies and treatment centers to streamline access.

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Financial Trajectory and Revenue Forecasts

Sales Projections

Based on initial uptake and limited patient pools, early revenues are modest but poised for growth. Industry analysts project U.S. sales reaching approximately $300 million by 2025, assuming steady physician adoption and expansion into Europe [4].

Revenue Drivers

• Market penetration: Targeted education campaigns and clinical guideline inclusion.
• Reimbursement success: Maximizing coverage to reduce out-of-pocket costs.
• New indications: Potential expansion into other thrombotic or hematological disorders.

profitability Outlook

Given high R&D and manufacturing costs, breakeven may occur within 5-7 years post-launch if market uptake remains steady. Cost management and pipeline development underpin long-term profitability.

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Regulatory and Market Influencers

Regulatory Developments

Ongoing regulatory interactions, including potential Pediatric Investigational Plans (PIPs) and real-world evidence collection, will influence KATERZIA’s market entry in additional regions.

Healthcare Trends

Growing emphasis on personalized medicine and rapid-response biologics align with KATERZIA’s therapeutic profile. Additionally, the expansion of outpatient treatment settings could reduce healthcare costs, making KATERZIA an attractive option.

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Future Outlook and Strategic Considerations

Pipeline and Indication Expansion

While presently approved solely for aTTP, research into related pathways—such as other thrombotic microangiopathies—may offer future development opportunities. Collaborations or acquisitions could bolster the treatment landscape for hematological disorders.

Market Growth Opportunities

The total addressable market remains constrained by rarity, but strategic international expansion, combined with improved disease recognition, can enhance revenue streams. Also, development of biosimilars or novel formulations may influence pricing dynamics.

Challenges and Risks

• Pricing pressures and potential reimbursement hurdles.
• Limited patient numbers inherently restrict sales potential.
• Competition from future therapeutics or generic biologics.

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Key Takeaways

• KATERZIA’s market success hinges on physician adoption, reimbursement strategies, and geographic expansion, given the rarity of aTTP.
• Clinical advantages over conventional therapy position KATERZIA as a transformative treatment, supporting robust demand forecasts.
• Pricing and reimbursement will significantly influence its financial trajectory, with value-based payment models expected to facilitate access.
• International regulatory approvals and expanding indications will be critical to sustaining revenue growth.
• Long-term profitability depends on pipeline evolution and market penetration, amidst ongoing healthcare shifts toward personalized biologics.

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FAQs

1. What is the primary clinical benefit of KATERZIA in treating aTTP?
KATERZIA provides rapid inhibition of microvascular thrombosis, reducing relapse rates and improving survival outcomes in aTTP patients, compared to conventional plasma-exchange therapies.

2. How does KATERZIA’s mechanism differ from traditional treatments?
KATERZIA is a targeted nanobody that inhibits von Willebrand factor-mediated platelet aggregation, offering a focused approach versus plasma exchange, which non-specifically removes plasma components.

3. What are the main challenges in commercializing KATERZIA?
Key challenges include limited patient populations, securing favorable reimbursement, physician awareness, and navigating international regulatory pathways.

4. What is the potential for expansion into other indications?
While initially approved for aTTP, future research could explore efficacy in related thrombotic microangiopathies, pending clinical trials and regulatory evaluations.

5. How does KATERZIA’s pricing impact its market feasibility?
High treatment costs are justified by its orphan designation and clinical benefits; however, payers’ acceptance depends on demonstrated cost-effectiveness and value propositions.

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Sources

1. [1] Klausner JD, et al. Management of acquired thrombotic thrombocytopenic purpura. Blood Adv. 2019.
2. [2] Scully M, et al. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019.
3. [3] Industry reports on orphan drug pricing 2023.
4. [4] Market analysis forecasts published by EvaluatePharma, 2023.