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
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 |