LOTREL Drug Patent Profile
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When do Lotrel patents expire, and when can generic versions of Lotrel launch?
Lotrel is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lotrel
A generic version of LOTREL was approved as amlodipine besylate; benazepril hydrochloride by LUPIN PHARMS on February 5th, 2010.
Summary for LOTREL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 75 |
Clinical Trials: | 9 |
Patent Applications: | 4,296 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LOTREL |
What excipients (inactive ingredients) are in LOTREL? | LOTREL excipients list |
DailyMed Link: | LOTREL at DailyMed |
Paragraph IV (Patent) Challenges for LOTREL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LOTREL | Capsules | amlodipine besylate; benazepril hydrochloride | 5 mg/40 mg and 10 mg/40 mg | 020364 | 1 | 2006-11-17 |
LOTREL | Capsules | amlodipine besylate; benazepril hydrochloride | 2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg | 020364 | 1 | 2004-06-09 |
US Patents and Regulatory Information for LOTREL
Expired US Patents for LOTREL
International Patents for LOTREL
See the table below for patents covering LOTREL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Egypt | 16987 | PROCESS FOR PREPARING NOVEL 1,4-DIHYDROPYRIDINE DERIVATIVES | ⤷ Try a Trial |
Norway | 170275 | ⤷ Try a Trial | |
Denmark | 171257 | ⤷ Try a Trial | |
Argentina | 243162 | PROCEDIMIENTO PARA OBTENER NOVEDOSOS ACIDOS 3-(5-AMINOPENTIL)-AMINO-1-BENZAZEPIN-2-ONA-1-ALCANOICOS. (3-AMINO-(1)-BENZAZEPIN-2-ONE-1-ALKANOIC ACIDS) | ⤷ Try a Trial |
Argentina | 240807 | PROCEDIMIENTO PARA OBTENER DERIVADOS DE BENZAZEPIN-2-ONA Y SUS SALES | ⤷ Try a Trial |
Hungary | 192394 | PROCESS FOR PREPARING DERIVATIVES OF 3-/5-AMINO-PENTYL/-AMINO-1-BENZAZEPIN-2-ONE-1-ALKANE-CARBOXYLIC ACID AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS | ⤷ Try a Trial |
Hong Kong | 97592 | 3-(5-AMINOPENTYL)-AMINO-1-BENZAZEPIN-2-ONE-1-ALCANOIC ACIDS,PROCESS FOR THEIR PREPARATION,THEIR PHARMACEUTICAL PREPARATION AS WELL AS THEIR THERAPEUTIC USE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LOTREL
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 |
0443983 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
0089167 | SPC/GB93/046 | United Kingdom | ⤷ Try a Trial | SPC/GB93/046: 20040307 |
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 |
0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
0503785 | C300486 | Netherlands | ⤷ Try a Trial | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |