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Last Updated: October 18, 2021

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Amlodipine benzoate - Generic Drug Details

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What are the generic drug sources for amlodipine benzoate and what is the scope of patent protection?

Amlodipine benzoate is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine benzoate has seven patent family members in four countries.

There are fifty drug master file entries for amlodipine benzoate. One supplier is listed for this compound.

Summary for amlodipine benzoate
Pharmacology for amlodipine benzoate
Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE
Tradename Dosage Ingredient NDA Submissiondate
KATERZIA SUSPENSION;ORAL amlodipine benzoate 211340 2020-12-29

US Patents and Regulatory Information for amlodipine benzoate

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 amlodipine benzoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 92315 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785 C300375 Netherlands ⤷  Free Forever 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
1507558 12C0033 France ⤷  Free Forever 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
0443983 C00443983/03 Switzerland ⤷  Free Forever Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Colorcon
Express Scripts
Harvard Business School
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.