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Last Updated: September 29, 2023

Atorvastatin calcium - Generic Drug Details

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

Atorvastatin calcium is the generic ingredient in five branded drugs marketed by Cmp Dev Llc, 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-eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atorvastatin calcium has two patent family members in two countries.

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

Summary for atorvastatin calcium

International Patents:	2
US Patents:	2
Tradenames:	5
Applicants:	27
NDAs:	28
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	60
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	69
Patent Applications:	7,483
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

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Recent Clinical Trials for atorvastatin calcium

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Sponsor	Phase
United States Department of Defense	Phase 2
University of California, San Francisco	Phase 2
Khyber Medical University Peshawar	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

Anatomical Therapeutic Chemical (ATC) Classes for atorvastatin calcium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Umedica Labs Pvt Ltd	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	213853-003	Aug 19, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lepu Pharm	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	216848-001	Nov 3, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Graviti Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	209912-004	Jun 18, 2018	AB	RX	No	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 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 a Trial	⤷ Try a Trial
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	⤷ Try a Trial	⤷ Try a Trial
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for atorvastatin calcium

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017212409		⤷ Try a Trial
European Patent Office	3468606	NOUVELLE COMPOSITION PHARMACEUTIQUE DE COMPOSÉ HYPOLIPIDÉMIANT (A NOVEL PHARMACEUTICAL COMPOSITION OF A LIPID LOWERING COMPOUND)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for atorvastatin calcium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	SZ 30/2006	Austria	⤷ Try a Trial	PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0247633	62/1997	Austria	⤷ Try a Trial	PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
1003503	30/2006	Austria	⤷ Try a Trial	PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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