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Last Updated: October 25, 2021

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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, Alkem Labs Ltd, Apotex Inc, August, Dr Reddys Labs Ltd, Graviti Pharms, Invagen Pharms, Lannett Co Inc, 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, Scov3, and Organon, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-two 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:	23
NDAs:	25
Drug Master File Entries:	62
Finished Product Suppliers / Packagers:	58
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	51
Patent Applications:	7,539
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
GCP-unit at Odense University Hospital	N/A
Odense Patient Data Explorative Network	N/A
Lars Peter Riber	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

Paragraph IV (Patent) Challenges for ATORVASTATIN CALCIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
LIPITOR	TABLET;ORAL	atorvastatin calcium	020702

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
Graviti Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	209912-001	Jun 18, 2018	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Teva Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	078773-003	May 29, 2012		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Scov3	EZETIMIBE AND ATORVASTATIN CALCIUM	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-004	Apr 26, 2017		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Scov3	EZETIMIBE AND ATORVASTATIN CALCIUM	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-003	Apr 26, 2017		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Accord Hlthcare	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	207687-004	Mar 30, 2018	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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	020702-003	Dec 17, 1996	⤷ Try it Free	⤷ Try it Free
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	⤷ Try it Free	⤷ Try it Free
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	⤷ Try it Free	⤷ Try it Free
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Try it Free	⤷ Try it Free
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.