CADUET Drug Patent Profile
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When do Caduet patents expire, and what generic alternatives are available?
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
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 | 021540-003 | Jan 30, 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 | 021540-003 | Jan 30, 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 | 021540-010 | 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 |
|---|---|---|---|
| African Regional IP Organization (ARIPO) | 1225 | Therapeutic combinations. | ⤷ Try a Trial |
| Sweden | 8701348 | ⤷ Try a Trial | |
| Tunisia | SN98156 | ASSOCIATIONS PHARMACEUTIQUES D'AMLODIPINE ET D'ATORVASTATINE ET PROCEDE POUR LEUR PREPARATION | ⤷ Try a Trial |
| Hungary | 196962 | PROCESS FOR PRODUCING AMLODIPIN-BEZILATE | ⤷ Try a Trial |
| Czechoslovakia | 240954 | PREPARATION METHOD OF 1,2-DIHYDROPYRIDINES | ⤷ Try a Trial |
| Ireland | 830520 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 0089167 | SPC/GB93/046 | United Kingdom | ⤷ Try a Trial | SPC/GB93/046: 20040307 |
| 1003503 | C01003503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 |
| 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 |
| 0247633 | 62/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107 |
| >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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