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.
Summary for NORVASC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 132 |
Clinical Trials: | 58 |
Patent Applications: | 2,685 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NORVASC |
What excipients (inactive ingredients) are in NORVASC? | NORVASC excipients list |
DailyMed Link: | NORVASC at DailyMed |
Recent Clinical Trials for NORVASC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Accutest Research Laboratories (I) Pvt. Ltd. | Phase 1 |
Brillian Pharma Inc. | Phase 1 |
Overseas Pharmaceuticals, Ltd. | Phase 1 |
Pharmacology for NORVASC
Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NORVASC
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 |