NORVASC Drug Patent Profile
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Which patents cover Norvasc, 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 | 019787-002 | 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 |
| 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 |
| >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 |
|---|---|---|---|
| Greece | 870525 | IMPROVEMENTS IN PHARMACEUTICALLY ACCEPTABLE SALTS | ⤷ Try a Trial |
| Czechoslovakia | 8401592 | ⤷ Try a Trial | |
| Latvia | 5619 | Panemiens 2-(2-aminoetoksimetil)-4-(2-hlorfenil)-6-metil-1,4-dihidropiridina-3,5-dikarbonskabes 3-etil-5-metilestera benzolsulfoskabes sais iegusanai | ⤷ Try a Trial |
| Norway | 864435 | ⤷ 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 | 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 |
| 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 |
| 1003503 | 05C0048 | France | ⤷ Try a Trial | 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 |
| 0089167 | SPC/GB93/046 | United Kingdom | ⤷ Try a Trial | SPC/GB93/046: 20040307 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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