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, 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, Macleods Pharms Ltd, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Shandong Xinhua, Strides Pharma, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Umedica, Zydus Pharms, Upjohn, Organon, and Althera Pharms, and is included in thirty-six NDAs. There are three 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-six suppliers are listed for this compound.

Summary for ATORVASTATIN CALCIUM

International Patents:	2
US Patents:	3
Tradenames:	5
Applicants:	35
NDAs:	36
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	71
Patent Applications:	7,051
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
Pharma Medica Research, Inc.	Phase 1
NewAmsterdam Pharma	Phase 1
United States Department of Defense	Phase 2

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
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Agnitio	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	214969-002	Sep 2, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	217081-004	Jan 5, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
>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		⤷ Sign Up
European Patent Office	3468606	NOUVELLE COMPOSITION PHARMACEUTIQUE DE COMPOSÉ HYPOLIPIDÉMIANT (A NOVEL PHARMACEUTICAL COMPOSITION OF A LIPID LOWERING COMPOUND)	⤷ Sign Up
>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	CR 2014 00050	Denmark	⤷ Sign Up	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
0720599	92545	Luxembourg	⤷ Sign Up	PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
1003503	05C0048	France	⤷ Sign Up	PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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