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Last Updated: September 29, 2020

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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 is one patent protecting this drug.

This drug has three 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.

US ANDA Litigation and 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.

Indicators of Generic Entry

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Summary for KATERZIA
Drug patent expirations by year for KATERZIA
Drug Prices for KATERZIA

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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

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   Start Trial   Start Trial Y   Start Trial
>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
1003503 05C0048 France   Start 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
1507558 12C0033 France   Start 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: 6167801 20110705
0503785 C300375 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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