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Last Updated: June 18, 2021

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KATERZIA Drug 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 four patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in three 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 October 16, 2037. This may change due to patent challenges or generic licensing.

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:5
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 5
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

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KATERZIA
Generic Entry Date for KATERZIA*:
Constraining patent/regulatory exclusivity:
NDA:
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
Paragraph IV (Patent) Challenges for KATERZIA
Tradename Dosage Ingredient NDA Submissiondate
KATERZIA SUSPENSION;ORAL amlodipine benzoate 211340 2020-12-29

US Patents and Regulatory Information for KATERZIA

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

Supplementary Protection Certificates for KATERZIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 CA 2011 00026 Denmark   Try Before You Buy 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
0443983 2007C/043 Belgium   Try Before You Buy PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983 C300445 Netherlands   Try Before You Buy PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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