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Last Updated: March 19, 2024

Amlodipine besylate; atorvastatin calcium - Generic Drug Details


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What are the generic drug sources for amlodipine besylate; atorvastatin calcium and what is the scope of freedom to operate?

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Mylan, Zydus Pharms, and Pharmacia, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Recent Clinical Trials for amlodipine besylate; atorvastatin calcium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
Dr. Reddy's Laboratories LimitedPhase 1

See all amlodipine besylate; atorvastatin calcium clinical trials

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
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 amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 207762-010 Jan 11, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-009 Nov 29, 2013 AB RX No 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
>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 amlodipine besylate; atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-001 Jan 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pharmacia CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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