Amlodipine benzoate - Generic Drug Details
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What are the generic sources for amlodipine benzoate and what is the scope of patent protection?
Amlodipine benzoate
is the generic ingredient in two branded drugs marketed by Amneal and Azurity, and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amlodipine benzoate has eleven patent family members in six countries.
Two suppliers are listed for this compound.
Summary for amlodipine benzoate
| International Patents: | 11 |
| US Patents: | 10 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Patent Applications: | 12 |
| DailyMed Link: | amlodipine benzoate at DailyMed |
Pharmacology for amlodipine benzoate
| Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for amlodipine benzoate
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | AMLODIPINE BENZOATE | amlodipine benzoate | SUSPENSION;ORAL | 215035-001 | Jun 13, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| China | 112334134 | 氨氯地平制剂 (AMLODIPINE FORMULATIONS) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2018067959 | ⤷ Try a Trial | |
| Canada | 3038989 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Try a Trial |
| Canada | 3096101 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for amlodipine benzoate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1915993 | C300625 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
| 0503785 | CA 2011 00026 | Denmark | ⤷ Try a Trial | 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 a Trial | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| 1507558 | 12C0033 | France | ⤷ Try a 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: CH - 6167801 20110705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
ISSN: 2162-2639
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