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Last Updated: March 28, 2024

NORVASC Drug Patent Profile


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When do Norvasc patents expire, and what generic alternatives are available?

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-six 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
Accutest Research Laboratories (I) Pvt. Ltd.Phase 1
Brillian Pharma Inc.Phase 1
Overseas Pharmaceuticals, Ltd.Phase 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 019787-001 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 019787-002 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
German Democratic Republic 265142 VERFAHREN ZUR HERSTELLUNG DES BESYLATSALZES VON AMLODIPIN ⤷  Try a Trial
Australia 573123 ⤷  Try a Trial
Spain 526459 ⤷  Try a Trial
Czech Republic 289095 ⤷  Try a Trial
African Regional IP Organization (ARIPO) 50 Improvements in pharmaceutially acceptable salts. ⤷  Try a Trial
United Kingdom 8707653 ⤷  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
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
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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
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
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

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