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Last Updated: March 29, 2024

katerzia Drug Patent Profile


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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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has ten 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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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 twelve US patents.

Patents protecting katerzia

Amlodipine formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTENSION

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HYPERTENSION

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial
Patented Use: ANGINA PECTORIS

Amlodipine formulations
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Patent Expiration: ⤷  Try a Trial
Patented Use: ANGINA


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Patent Expiration: ⤷  Try a Trial


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Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE


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Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING HYPERTENSION


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 22872
Estimated Expiration: ⤷  Try a Trial

Patent: 60158
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 86067
Estimated Expiration: ⤷  Try a Trial

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
China 112334134 氨氯地平制剂 (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
Canada 3038989 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
Canada 3096101 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
Spain 2886067 ⤷  Try a Trial
European Patent Office 3773574 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
European Patent Office 3522872 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
European Patent Office 3960158 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for katerzia

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 2012/018 Ireland ⤷  Try a Trial 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
1003503 05C0048 France ⤷  Try a Trial PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
1915993 C300625 Netherlands ⤷  Try a Trial 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 C300445 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1507558 12C0033 France ⤷  Try a Trial 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
0503785 C300375 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0503785 C300486 Netherlands ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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