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 |
|---|---|---|---|
| United Kingdom | 2188630 | IMPROVEMENTS IN PHARMACEUTICALLY ACCEPTABLE SALTS | ⤷ Try a Trial |
| European Patent Office | 0119955 | 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 |
| European Patent Office | 0244944 | SALTS OF AMLODIPINE | ⤷ Try a Trial |
| Slovenia | 8310586 | PROCESS FOR OBTAINING 1,4-DIHYDROPYRIDINE | ⤷ Try a Trial |
| Canada | 1196636 | BENZAZEPIN-2-ONES (BENZAZEPIN-2-ONES) | ⤷ Try a Trial |
| Poland | 250767 | ⤷ Try a Trial | |
| Latvia | 5619 | Panemiens 2-(2-aminoetoksimetil)-4-(2-hlorfenil)-6-metil-1,4-dihidropiridina-3,5-dikarbonskabes 3-etil-5-metilestera benzolsulfoskabes sais iegusanai | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 0502314 | C300478 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
| 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 |
| 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 |
| 0502314 | SPC/GB11/010 | United Kingdom | ⤷ Try a Trial | 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 |
| 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 |
| 1003503 | 05C0048 | France | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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