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Generated: June 28, 2017
What is the patent landscape for Caduet, and what generic Caduet alternatives are available?
Caduet is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 74 |
| Clinical Trials: see list | 10 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | CADUET at DailyMed |
| Ingredient-type | Dihydropyridines |
| Drug Class | Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Calcium Channel Antagonists Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-009 | Jul 29, 2004 | AB | RX | Yes | No | 6,455,574 | ► Subscribe | ► Subscribe | |||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-006 | Jan 30, 2004 | AB | RX | Yes | No | 5,969,156*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-001 | Jan 30, 2004 | AB | RX | Yes | No | 6,455,574 | ► Subscribe | ► Subscribe | |||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-010 | Jul 29, 2004 | AB | RX | Yes | No | 5,969,156*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-003 | Jan 30, 2004 | AB | RX | Yes | No | 5,969,156*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-007 | Jan 30, 2004 | 4,681,893*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-006 | Jan 30, 2004 | 6,126,971*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-004 | Jan 30, 2004 | RE40667*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-005 | Jan 30, 2004 | 5,969,156*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-004 | Jan 30, 2004 | 5,969,156*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| amlodipine besylate and atorvastatin calcium | Tablets | 2.5 mg/40 mg | Caduet | 9/17/2009 |
| amlodipine besylate and atorvastatin calcium | Tablets | 5 mg/80 mg | Caduet | 4/7/2009 |
| amlodipine besylate and atorvastatin calcium | Tablets | 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg | Caduet | 12/29/2006 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Turkey | 200000561 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 122118 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1148049 | ► Subscribe | |||||||||||||||||||||||||||
| African Intellectual Property Organization (OAPI) | 11290 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 003458 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0033 | France | ► Subscribe | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705 | ||||||||||||||||||||||||||
| 00375 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 00528 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 | ||||||||||||||||||||||||||
| 07C/043 | Belgium | ► Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||||||||||||||||
| 00478 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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