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-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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for NORVASC?
- What are the global sales for NORVASC?
- What is Average Wholesale Price for NORVASC?
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: | 3,714 |
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 |
![NORVASC drug patent expirations Drug patent expirations by year for NORVASC](/p/graph/s/t/NORVASC-patent-expirations.png)
![Drug Prices for NORVASC](/p/graph/drug-price/NORVASC.png)
![Drug Sales Revenue Trends for NORVASC](/p/graph/drug-sales-revenues/NORVASC.png)
Recent Clinical Trials for NORVASC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brillian Pharma Inc. | Phase 1 |
Accutest Research Laboratories (I) Pvt. Ltd. | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-003 | Jul 31, 1992 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | 019787-003 | Jul 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-001 | Jul 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-003 | Jul 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
New Zealand | 203521 | DIHYDROPYRIDINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
Czechoslovakia | 8301499 | ⤷ Sign Up | |
Yugoslavia | 43541 | ⤷ Sign Up | |
Austria | 49752 | ⤷ Sign Up | |
Czechoslovakia | 8401592 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | 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 |
1915993 | 92315 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
1915993 | 300625 | Netherlands | ⤷ Sign Up | 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 |
1003503 | 05C0048 | France | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
0503785 | CA 2011 00026 | Denmark | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |