CADUET Drug Patent Profile
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When do Caduet patents expire, 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 | |||
>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 | 021540-010 | Jul 29, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-009 | Jul 29, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacia | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-006 | 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 |
---|---|---|---|
Finland | 872365 | ⤷ Try a Trial | |
Croatia | P930369 | PROCESS FOR THE PREPARATION OF 1,4 DIHYDROPYRIDINE | ⤷ Try a Trial |
Czech Republic | 294108 | Krystalická forma I hydrátu atorvastatinuŹ tj@ semivápenaté soli kyseliny [R@}RgŹRgB]@}@fluorfenylB@betaŹdelta@dihydroxy@Q@}�@methylethylB@fenyl[}fenylaminoBkarbonyl]@�H@pyrrol@�@heptanové (Crystalline form I of atorvastatin hydrate, i.e. [R-(R*,R*)]-2-(4-fluorophenyl)- beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt) | ⤷ 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 |
---|---|---|---|---|
0247633 | C970034 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107 |
1003503 | C01003503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 |
1507558 | 2012/018 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |