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Last Updated: November 8, 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 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
Patent Number: ⤷  Sign Up
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
World Intellectual Property Organization (WIPO) 2019200143 ⤷  Sign Up
Canada 3038989 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Sign Up
Canada 3096101 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) ⤷  Sign Up
China 112334134 氨氯地平制剂 (AMLODIPINE FORMULATIONS) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2018067959 ⤷  Sign Up
>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 ⤷  Sign Up 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
0443983 C300445 Netherlands ⤷  Sign Up PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0503785 C300375 Netherlands ⤷  Sign Up 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
1915993 C300625 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
0503785 CA 2011 00026 Denmark ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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