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Last Updated: April 20, 2024

Atorvastatin calcium - Generic Drug Details

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

Atorvastatin calcium is the generic ingredient in five branded drugs marketed by Cmp Dev Llc, Accord Hlthcare, ACI, Agnitio, Alkem Labs Ltd, Anbison Lab, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Invagen Pharms, Lannett Co Inc, Laurus, Lepu Pharm, Lupin Ltd, Mankind Pharma, 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, Zydus Pharms, Upjohn, Organon, and Althera Pharms, and is included in thirty-five 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-three suppliers are listed for this compound.

Summary for atorvastatin calcium

International Patents:	2
US Patents:	2
Tradenames:	5
Applicants:	34
NDAs:	35
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	63
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	69
Patent Applications:	7,598
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
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

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
Biocon Pharma	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	216436-002	Nov 23, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sciegen Pharms Inc	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	205519-004	May 19, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mankind Pharma	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	217081-002	Jan 5, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	206536-001	Nov 20, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	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 atorvastatin calcium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	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
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	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
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	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
0720599	122014000088	Germany	⤷ Try a Trial	PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
0720599	300689	Netherlands	⤷ Try a Trial	PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
0247633	97C0118	France	⤷ Try a Trial	PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
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
0720599	CR 2014 00050	Denmark	⤷ Try a Trial	PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.