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, ACI, 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, Mankind Pharma, Micro Labs Ltd India, MSN, Mylan Pharms Inc, Perrigo R And D, Sandoz Inc, Sciegen Pharms Inc, Shandong Xinhua, 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 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-three suppliers are listed for this compound.

Summary for ATORVASTATIN CALCIUM

International Patents:	2
US Patents:	3
Tradenames:	5
Applicants:	34
NDAs:	35
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	63
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	71
Patent Applications:	7,454
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
Pharma Medica Research, Inc.	Phase 1
NewAmsterdam Pharma	Phase 1
University of California, San Francisco	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
Zydus Pharms	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	206536-002	Nov 20, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	214344-004	Sep 12, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cadila Pharms Ltd	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	212103-001	Oct 16, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	217081-003	Jan 5, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocon Pharma	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	216436-004	Nov 23, 2022	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	020702-002	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	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
0247633	97C0118	France	⤷ Sign Up	PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
0720599	122014000088	Germany	⤷ Sign Up	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
1003503	C01003503/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
1003503	SZ 30/2006	Austria	⤷ Sign Up	PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
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
0247633	C970034	Netherlands	⤷ Sign Up	PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
>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.