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Last Updated: March 29, 2024

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.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-007 Apr 11, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-003 Mar 3, 1995 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 AB RX Yes No ⤷  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

Expired US Patents for LOTREL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-005 Jun 20, 2002 ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LOTREL

See the table below for patents covering LOTREL around the world.

Country Patent Number Title Estimated Expiration
Morocco 20938 ⤷  Try a Trial
Argentina 244211 PROCEDIMIENTO PARA LA ELABORACION DE ACIDOS 3-AMINO-(1)BENZAZEPIN-2-ONA-1-ALCANOICOS Y SUS SALES Y ESTEROISOMEROS. (BENZAZEPIN-2-ONES, PROCESS FOR THEIR PREPARATION, PHARMACEUTICAL PREPARATIONS CONTAINING THESE COMPOUNDS AND THEIR THERAPEUTICAL USE) ⤷  Try a Trial
Japan S58167569 NOVEL DIHYDROPYRIDINE COMPOUND AND ANTITHROMBOTIC, ANTIHYPERTENSIVE ⤷  Try a Trial
Slovenia 8511419 PROCESS FOR OBTAINING 1,4-DIHYDROPYRIDINE ⤷  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
1507558 C300528 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
1915993 92315 Luxembourg ⤷  Try a 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 ⤷  Try a 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
0089167 SPC/GB93/046 United Kingdom ⤷  Try a Trial SPC/GB93/046: 20040307
>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.