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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Katerzia

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for KATERZIA

International Patents:	11
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	11
Drug Prices:	Drug price information 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 fifteen 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	10,959,991
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,918,685
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,952,998		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,364,230		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,894,039
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,471,409
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,701,326		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
Canada	3038989	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2019200143
Japan	7456933
European Patent Office	3960158
Canada	3038989
World Intellectual Property Organization (WIPO)	2018067959
China	112334134	氨氯地平制剂 (AMLODIPINE FORMULATIONS)

Supplementary Protection Certificates for KATERZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
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
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
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216

KATERZIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Katerzia (Amlodipine Oral Suspension)

Introduction to Katerzia

Katerzia, an oral suspension formulation of amlodipine, was approved by the U.S. Food and Drug Administration (FDA) in July 2019. It is the first and only FDA-approved amlodipine oral suspension, indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, as well as coronary artery disease in adults[1][4].

Market Need and Target Population

Katerzia addresses a significant need in the market by providing a ready-to-use oral suspension, which is particularly beneficial for pediatric patients and individuals who have difficulty swallowing conventional tablets or capsules. This formulation simplifies dosing for children, ensuring safe and effective treatment[1].

Competitive Landscape

As of the approval date, Katerzia is available as a brand-name drug only, with no generic version available. This gives Azurity Pharmaceuticals a unique market position, especially in the pediatric hypertension segment. The lack of generic competition allows Katerzia to capture a significant share of the market for patients requiring an oral liquid option of amlodipine[2].

Pricing and Accessibility

The cost for Katerzia oral suspension is around $628 for a 150 milliliter supply, depending on the pharmacy. However, Azurity Pharmaceuticals offers various savings and support programs to make the medication more accessible. These programs include automatic co-pay discounts at over 70,000 participating pharmacies, ensuring that most commercially insured patients can obtain the medication for as low as $0 per prescription[2][5].

Insurance Coverage and Patient Assistance

Katerzia is covered under commercial insurance and Medicaid in all 50 states, enhancing its accessibility. The Azurity Solutions Patient Assistance Program provides financial support to eligible patients, ensuring that access to Katerzia is not limited by financial constraints[5].

Manufacturing and Distribution

Katerzia is manufactured by Azurity Pharmaceuticals, a company formed by the acquisition of Silvergate Pharmaceuticals by CutisPharma. The manufacturing process involves a ready-to-use aqueous formulation containing 1 mg/mL of amlodipine, filled in 185-cc round white, opaque, high-density polyethylene bottles. The FDA has approved all the manufacturing facilities involved in the production of Katerzia[1][4].

Financial Trajectory

Given its unique market position and the absence of generic competition, Katerzia is likely to generate significant revenue for Azurity Pharmaceuticals. The drug's approval marked an important milestone for the company, strengthening its portfolio of pediatric hypertension treatments.

Revenue Potential

The revenue potential for Katerzia is substantial, particularly given the high demand for user-friendly drug formulations, especially among pediatric patients. With its extensive distribution network and coverage under major insurance plans, Katerzia is poised to capture a significant share of the market for calcium channel blockers used in treating hypertension and coronary artery disease.

Cost Savings and Patient Compliance

By offering a ready-to-use oral suspension, Katerzia can improve patient compliance, especially among children, which can lead to better health outcomes and potentially reduce long-term healthcare costs. Improved compliance and the convenience of the formulation can also contribute to increased market share and revenue.

Market Trends and Dynamics

The pharmaceutical market is dynamic, with spending patterns shifting over time due to innovation, patent expirations, and changes in disease prevalence. Katerzia benefits from being part of a class of drugs that continues to be important in treating cardiovascular diseases, which remain a significant health concern globally[3].

Industry Expert Insights

Industry professionals highlight the importance of user-friendly drug formulations, especially for pediatric and elderly patients. "The addition of Katerzia complements our existing pediatric hypertension portfolio and will strengthen the overall offering from Azurity," said Neal Muni, MD, MSPH, President and Chief Executive Officer of Azurity Pharmaceuticals[1].

Regulatory Environment

The FDA approval of Katerzia underscores the regulatory body's commitment to ensuring that safe and effective treatments are available for all patient populations. The approval process involved rigorous reviews, including assessments of the formulation design, excipient selection, and manufacturing facilities, ensuring that Katerzia meets high standards of quality and safety[4].

Conclusion

Katerzia represents a significant advancement in the treatment of hypertension and coronary artery disease, particularly for pediatric patients. Its unique formulation, extensive distribution network, and comprehensive patient support programs position it for strong market performance and financial growth.

Key Takeaways

• First FDA-Approved Amlodipine Oral Suspension: Katerzia is the first and only FDA-approved amlodipine oral suspension.
• Target Population: Indicated for adults and pediatric patients 6 years and older.
• Pricing and Accessibility: Available at over 70,000 pharmacies with automatic co-pay discounts.
• Insurance Coverage: Covered under commercial insurance and Medicaid in all 50 states.
• Patient Assistance: Azurity Solutions Patient Assistance Program provides financial support.
• Revenue Potential: Significant revenue potential due to unique market position and lack of generic competition.

FAQs

Q: What is Katerzia used for?

Katerzia is used for the treatment of hypertension in adults and pediatric patients 6 years of age and older, as well as coronary artery disease in adults.

Q: How is Katerzia administered?

Katerzia is administered as a ready-to-use oral suspension, which simplifies dosing for patients who have difficulty swallowing tablets or capsules.

Q: Is Katerzia covered by insurance?

Yes, Katerzia is covered under commercial insurance and Medicaid in all 50 states.

Q: Are there any patient assistance programs available for Katerzia?

Yes, the Azurity Solutions Patient Assistance Program provides financial support to eligible patients.

Q: How much does Katerzia cost?

The cost for Katerzia oral suspension is around $628 for a 150 milliliter supply, but it can be obtained for as low as $0 per prescription through various savings programs.

Sources

1. FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension - PR Newswire
2. Katerzia Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Understanding the Dynamics of Drug Expenditure - IQVIA
4. Other Review(s) - KATERZIA (amlodipine benzoate) oral suspension - FDA
5. Savings and Support for Rx KATERZIA® (amlodipine) Oral Liquid - Katerzia.com