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Last Updated: February 4, 2023

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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine benzoate has ten patent family members in six countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for amlodipine benzoate
International Patents:10
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 6
Patent Applications: 10
DailyMed Link:amlodipine benzoate at DailyMed
Generic filers with tentative approvals for AMLODIPINE BENZOATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1MG/ML(150ML)SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE
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 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 amlodipine benzoate

Country Patent Number Title Estimated Expiration
Spain 2886067 See Plans and Pricing
European Patent Office 3522872 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) See Plans and Pricing
European Patent Office 3960158 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) See Plans and Pricing
European Patent Office 3773574 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2019200143 See Plans and Pricing
Canada 3096101 FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for amlodipine benzoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1003503 05C0048 France See Plans and Pricing 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
0503785 C300486 Netherlands See Plans and Pricing 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
1507558 12C0033 France See Plans and Pricing 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
0443983 C00443983/03 Switzerland See Plans and Pricing PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314 SPC/GB11/010 United Kingdom See Plans and Pricing PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
1915993 92315 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
>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

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