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 three 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

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.

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
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

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
Spain	3035030

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
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216

KATERZIA (amlodipine?) Market Dynamics and Financial Trajectory: Unit Growth, Pricing, Exclusivity Levers, and Generic/Biosimilar Entry Risks

Last updated: July 30, 2026

Katerzia revenue trajectory is driven by US pediatric calcium-channel blocker demand, Medicaid and commercial formulary placement, and the speed of any generic erosion after exclusivity. The commercial outcome hinges on (1) FDA exclusivity and Orange Book-listed patent fences, (2) settlement outcomes that can cap Paragraph IV pressure, and (3) channel mix, especially nursing and pediatric specialty procurement.

What is KATERZIA and how is it positioned commercially?

Katerzia is the brand name for amlodipine besylate oral suspension/tablet formulations used in pediatric hypertension. Market positioning is centered on pediatric dosing convenience and guideline-aligned titration schedules rather than differentiation in mechanism.

How is Katerzia sold and distributed?

Commercial dynamics typically follow branded cardiovascular patterns:

• Retail and 340B influence: Pediatric hypertension prescriptions flow through both retail networks and pediatric-focused channels; pediatric indications widen prescriber base.
• Institutional uptake: Pediatric hospitals and community systems buy via group purchasing organizations, which can determine net pricing and rebates.
• Channel discounts: Managed care rebates and payer-specific access policies materially affect net sales versus list price.

What determines payer demand for pediatric antihypertensives?

Demand is shaped by:

• Step-therapy rules in commercial plans
• Medicaid preferred drug lists
• Plan policies for oral suspension versus solid dose
• Switching incentives tied to “preferred” generic amlodipine and any authorized generics

How do formulary and pricing dynamics affect Katerzia net sales?

The financial trajectory of a pediatric branded antihypertensive depends on how quickly payers steer to lower-cost amlodipine generics after patent/market entry barriers ease.

What are the main net sales drivers and headwinds?

Net sales typically move with:

• Pediatric hypertension incidence treated and prescriber persistence
• Formulary availability (tier placement, prior authorization)
• Rebate rate changes after generic entry threats
• Contracting with large pharmacy benefit managers (PBMs)

Headwinds usually come from:

• Generic substitution at the pharmacy counter
• Therapeutic interchange if plan rules permit
• Wholesale inventory rebalancing after initial stocking surges end

What pricing baselines matter for Katerzia?

For branded pediatric products, list price is less informative than:

• Net price after rebates
• Net-to-wholesale dynamics
• Medicaid reimbursement structure
• State-level preferred status for generics

What patents protect KATERZIA, and what is the patent-expiration timeline?

A full, litigation-grade patent fence requires a current Orange Book and patent listing set tied to each Katerzia NDA/BLA and dosage form. Without the complete listing set, the protection landscape and expiration schedule cannot be stated precisely.

What is the Orange Book status of KATERZIA?

Orange Book status must be verified for:

• NDA number(s)
• Dosage forms covered (suspension vs solid)
• Listed patents’ expiration dates and patent types (composition, formulation, method of use)

Without the NDA-linked Orange Book listing set, status cannot be stated accurately.

When does KATERZIA lose exclusivity, and what exclusivity types apply?

Exclusivity analysis depends on:

• Patent expiration dates on the specific listed NDA(s)
• FDA exclusivity periods (e.g., orphan or pediatric exclusivity if applicable)
• Any patent term extensions (PTE)
• Pediatric exclusivity triggers tied to labeling updates

A correct “lose exclusivity” timeline requires NDA-level exclusivity and patent-term data.

How many patents cover KATERZIA formulations and method-of-use claims?

Counting claims requires the full patent family inventory for:

• Formulations (e.g., suspension stability, buffering system, particle size, preservatives)
• Method-of-use (pediatric dosing regimens and hypertension management)
• Any combination of active ingredient plus excipient ranges

A quantified patent count cannot be provided without the underlying patent list.

What Paragraph IV challenges exist for KATERZIA, and who filed them?

Paragraph IV risk depends on:

• ANDA filers’ identities
• Drug product description (strength, dosage form)
• Certifications (Paragraph IV) tied to specific Orange Book patents

A litigation-accurate answer requires the ANDA challenge record set.

What patent litigation affects KATERZIA (settlements, injunctions, timelines)?

Litigation outcomes drive financial trajectory through:

• Entry dates
• “At-risk” launch risk
• Carve-outs in settlement agreements
• Triggered payments or delayed-launch commitments

A litigation-accurate account requires case captions, court, settlement dates, and patent(s)-in-suit.

What generic entry risks exist for KATERZIA and what launch scenarios are realistic?

Generic erosion typically follows:

• Pharmacy substitution once ANDA approval issues and any exclusivity barriers clear
• Contract renegotiation and accelerated rebate pressure by PBMs
• Retail demand migration to cheaper generics and authorized generics

But the probability, timing, and “who launches first” scenarios require Orange Book and ANDA status data.

How does KATERZIA compare with other pediatric antihypertensives on revenue durability?

Revenue durability for branded pediatric cardiovascular drugs usually correlates with:

• Strength of pediatric formulary placement
• Remaining patent life versus generic competitive set
• Availability of liquid formulations that are harder to replicate at low cost

A comparative revenue durability assessment requires verified sales data and competitor patent fences.

What manufacturing and IP barriers could delay generic substitution for KATERZIA?

Liquid pediatric formulations can create manufacturing/IP friction:

• Stability and shelf-life performance
• Particle size or suspension uniformity targets
• Container closure system constraints
• Excipient system claims (buffering agents, viscosity adjusters, preservatives)

A barrier-specific analysis requires the exact Katerzia formulation patent claims and manufacturing specs.

KATERZIA financial trajectory: what metrics show growth vs erosion?

For branded pediatric products, trajectory is best assessed using:

• US net sales and unit prescriptions (NBRx)
• Share of prescriptions versus generics
• Gross-to-net bridge showing rebate and discount shifts
• Quarterly pricing signals after generic launches (net price compression)

A numeric trajectory cannot be stated without Katerzia sales and prescription datasets.

Key Takeaways

• Katerzia’s financial trajectory is primarily a function of pediatric demand stability, net price integrity (rebates and payer access), and the speed of generic substitution once patent and exclusivity barriers fall.
• The most decision-relevant commercial driver is timing and certainty of generic entry, which depends on the Orange Book patent fence and any Paragraph IV litigation and settlement terms.
• A precise forecast requires NDA-specific Orange Book patent lists, exclusivity dates, ANDA challenge records, and litigation dockets tied to Katerzia’s specific dosage forms.

FAQs

1. What Orange Book patents are listed for KATERZIA pediatric amlodipine products by dosage form?
2. Which ANDA filers have challenged KATERZIA under Paragraph IV, and which patents did they certify to?
3. What settlement terms typically delay generic entry for pediatric antihypertensives like KATERZIA?
4. How do Medicaid preferred status changes typically affect net sales of branded pediatric cardiovascular drugs?
5. What formulation attributes most often drive IP barriers for pediatric oral suspensions in generic development?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. FDA Orange Book patent and exclusivity documentation for relevant NDA(s). FDA.
3. FDA ANDA Paragraph IV notices and related litigation filings (where applicable). FDA/RECAP docket sources.