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Last Updated: November 25, 2024

katerzia Drug Patent Profile


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When do Katerzia patents expire, and what generic alternatives are available?

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

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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: 9
Drug Prices: Drug price information for katerzia
What excipients (inactive ingredients) are in katerzia?katerzia excipients list
DailyMed Link:katerzia at DailyMed
Drug patent expirations by year for katerzia
Drug Prices for katerzia

See drug prices for katerzia

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.

Patents protecting katerzia

Amlodipine formulations
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Patent Expiration: ⤷  Sign Up

Amlodipine formulations
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Amlodipine formulations
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Patented Use: TREATMENT OF HYPERTENSION

Amlodipine formulations
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Patented Use: METHOD OF TREATING HYPERTENSION

Amlodipine formulations
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Amlodipine formulations
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Patented Use: ANGINA PECTORIS

Amlodipine formulations
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Patented Use: ANGINA


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Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE


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Patented Use: A METHOD OF TREATING HYPERTENSION


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Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE


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Patented Use: A METHOD OF TREATING HYPERTENSION


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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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 38989
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 22872
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 60158
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 86067
Estimated Expiration: ⤷  Sign Up

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
Spain 2886067 ⤷  Sign Up
European Patent Office 3522872 ⤷  Sign Up
European Patent Office 3522872 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Sign Up
European Patent Office 3773574 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Sign Up
European Patent Office 3960158 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for katerzia

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 C300486 Netherlands ⤷  Sign Up 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
0443983 C00443983/03 Switzerland ⤷  Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1915993 300625 Netherlands ⤷  Sign Up 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
0443983 2007C/043 Belgium ⤷  Sign Up PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1915993 92315 Luxembourg ⤷  Sign Up PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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