CADUET Drug Patent Profile
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Which patents cover Caduet, and when can generic versions of Caduet launch?
Caduet is a drug marketed by Pharmacia and is included in one NDA.
The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Caduet
A generic version of CADUET was approved as amlodipine besylate; atorvastatin calcium by MYLAN on November 29th, 2013.
Summary for CADUET
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 13 |
| Patent Applications: | 2,513 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CADUET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CADUET |
| What excipients (inactive ingredients) are in CADUET? | CADUET excipients list |
| DailyMed Link: | CADUET at DailyMed |
Paragraph IV (Patent) Challenges for CADUET
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 2.5 mg/40 mg | 021540 | 1 | 2009-09-17 |
| CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 5 mg/80 mg | 021540 | 1 | 2009-04-07 |
| CADUET | Tablets | amlodipine besylate; atorvastatin calcium | 5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg | 021540 | 1 | 2006-12-29 |
US Patents and Regulatory Information for CADUET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-009 | Jul 29, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-004 | Jan 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-001 | Jan 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-005 | Jan 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-010 | Jul 29, 2004 | AB | RX | Yes | No | ⤷ 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 CADUET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-005 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-003 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-008 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-007 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-003 | Jan 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CADUET
See the table below for patents covering CADUET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Morocco | 26535 | ⤷ Try a Trial | |
| Poland | 250767 | ⤷ Try a Trial | |
| Canada | 2301732 | COMBINAISONS THERAPEUTIQUES (THERAPEUTIC COMBINATIONS) | ⤷ Try a Trial |
| Japan | 2007137903 | SALT OF [R-(R*,R*)]-2-(4-FLUOROPHENYL)-beta,delta-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID | ⤷ Try a Trial |
| Georgia, Republic of | P20002029 | (54) Crystalline [R-(R*,R*,]-2-(4-Fluorophenyl)-Beta,Delta-Dihydroxy-5-(1-Methyl-Ethyl)-3-Phenyl-4-{Phenylamino) Carbonyl} - 1H - Pyrrole - 1 - Heptanoic Acid Hemi Calcium Salt (Atorvastatin) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CADUET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0089167 | SPC/GB93/046 | United Kingdom | ⤷ Try a Trial | SPC/GB93/046: 20040307 |
| 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 |
| 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 |
| 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 | 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 |
| >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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