Atorvastatin calcium - Generic Drug Details

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What are the generic drug sources for atorvastatin calcium and what is the scope of patent protection?

Atorvastatin calcium is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Agnitio, Alkem Labs Ltd, Apotex Inc, Biocon Pharma, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Invagen Pharms, Lannett Co Inc, Lepu Pharm, Lupin Ltd, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica Labs Pvt Ltd, Zydus Pharms, Upjohn, Organon, and Scov3, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty-five drug master file entries for atorvastatin calcium. Fifty-eight suppliers are listed for this compound.

Summary for atorvastatin calcium

US Patents:	0
Tradenames:	4
Applicants:	26
NDAs:	27
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	58
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	66
Patent Applications:	6,886
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for atorvastatin calcium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atorvastatin calcium
What excipients (inactive ingredients) are in atorvastatin calcium?	atorvastatin calcium excipients list
DailyMed Link:	atorvastatin calcium at DailyMed

Drug Sales Revenue Trends for atorvastatin calcium

See drug sales revenues for atorvastatin calcium

Recent Clinical Trials for atorvastatin calcium

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

Sponsor	Phase
Stony Brook University	Phase 3
Odense Patient Data Explorative Network	N/A
Odense University Hospital	N/A

See all atorvastatin calcium clinical trials

Pharmacology for atorvastatin calcium

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for atorvastatin calcium

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

US Patents and Regulatory Information for atorvastatin calcium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	091650-003	Jul 17, 2012	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mylan Pharms Inc	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	091226-002	May 29, 2012	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Scov3	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-002	Apr 26, 2017		RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Micro Labs Ltd India	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	205945-001	Nov 7, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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 atorvastatin calcium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	See Plans and Pricing	See Plans and Pricing
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	See Plans and Pricing	See Plans and Pricing
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	See Plans and Pricing	See Plans and Pricing
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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