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 | 020364-007 | Apr 11, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | LOTREL | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 020364-003 | Mar 3, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
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 | 020364-002 | 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 |
---|---|---|---|
China | 1023800 | ⤷ 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 |
German Democratic Republic | 202546 | VERFAHREN ZUR HERSTELLUNG VON NEUEN BENZAPETIN-2-ONEN | ⤷ Try a Trial |
South Korea | 890003425 | ⤷ 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 | 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 |
1507558 | 2012/018 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |