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 Pricing | See Plans and Pricing | 1MG/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.
Pharmacology for amlodipine benzoate
Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
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
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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