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Last Updated: March 19, 2024

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 Viatris and is included in one NDA.

The generic ingredient in NORVASC is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-seven 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 COREPHARMA 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
Brillian Pharma Inc.Phase 1
Accutest Research Laboratories (I) Pvt. Ltd.Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,LtdPhase 1

See all NORVASC clinical trials

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
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 AB RX Yes Yes ⤷  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 NORVASC

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

International Patents for NORVASC

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

Country Patent Number Title Estimated Expiration
Poland 140575 ⤷  Try a Trial
Czech Republic 289095 ⤷  Try a Trial
United Kingdom 8608335 ⤷  Try a Trial
Denmark 170187 ⤷  Try a Trial
Ireland 870869 ⤷  Try a Trial
Spain 2002599 UN PROCEDIMIENTO PARA LA PREPARACION DE LA SAL DE BESILATO DE AMLODIPINA (Salts of amlodipine.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NORVASC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
0503785 CA 2011 00026 Denmark ⤷  Try a Trial 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 a Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0443983 C300445 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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
>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.