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Details for Generic Name: atorvastatin calcium

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Atorvastatin calcium is the generic ingredient in three branded drugs marketed by Apotex Inc, Dr Reddys Labs Ltd, Kudco Ireland, Mylan Pharms Inc, Ranbaxy Labs Ltd, Sandoz Inc, Teva Pharms, Pfizer, and Merck Sharp Dohme, and is included in ten NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-seven drug master file entries for atorvastatin calcium. Seventeen suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

Drug Master File Entries: see list57
Suppliers: see list17
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: atorvastatin calcium

Clinical Trials for: atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXNo<disabled><disabled>
Ranbaxy Labs Ltd
atorvastatin calcium
TABLET;ORAL076477Nov 30, 2011RXNo<disabled><disabled>
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXYes<disabled><disabled>
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXYes5,969,156*PED<disabled>Y<disabled>
Apotex Inc
atorvastatin calcium
TABLET;ORAL090548May 29, 2012RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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