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Last Updated: October 27, 2021

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NORVASC Drug Patent Profile


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When do Norvasc patents expire, and when can generic versions of Norvasc launch?

Norvasc is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in NORVASC is amlodipine besylate. There are fifty drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Norvasc

A generic version of NORVASC was approved as amlodipine besylate by APOTEX on May 23rd, 2007.

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Drug patent expirations by year for NORVASC
Drug Prices for NORVASC

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Drug Sales Revenue Trends for NORVASC

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Recent Clinical Trials for NORVASC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticPhase 2
Weill Medical College of Cornell UniversityPhase 2
Fogarty International Center of the National Institute of HealthPhase 2

See all NORVASC clinical trials

Pharmacology for NORVASC
Paragraph IV (Patent) Challenges for NORVASC
Tradename Dosage Ingredient NDA Submissiondate
NORVASC TABLET;ORAL amlodipine besylate 019787

US Patents and Regulatory Information for NORVASC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 NORVASC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
Upjohn NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NORVASC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0443983 C00443983/03 Switzerland ⤷  Try it Free PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0678503 C300499 Netherlands ⤷  Try it Free 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 it Free 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
1507558 12C0033 France ⤷  Try it Free 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: 6167801 20110705
0503785 CA 2011 00026 Denmark ⤷  Try it Free 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
1915993 92315 Luxembourg ⤷  Try it Free PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0443983 2007C/043 Belgium ⤷  Try it Free PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Boehringer Ingelheim
McKesson
Medtronic
Express Scripts

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