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Last Updated: March 29, 2024

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 five branded drugs marketed by Cmp Dev Llc, Accord Hlthcare, ACI, Agnitio, Alkem Labs Ltd, Anbison Lab, Apotex Inc, 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-four 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-two suppliers are listed for this compound.

Drug Sales Revenue Trends for atorvastatin calcium

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Recent Clinical Trials for atorvastatin calcium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San FranciscoPhase 2
United States Department of DefensePhase 2
Himayat UllahN/A

See all atorvastatin calcium clinical trials

Pharmacology for atorvastatin calcium
Medical Subject Heading (MeSH) Categories for atorvastatin calcium

US Patents and Regulatory Information for atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Agnitio ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 214969-003 Sep 2, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cadila Pharms Ltd ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 212103-002 Oct 16, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 209288-004 Dec 21, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 091226-003 May 29, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Althera Pharms LYPQOZET atorvastatin calcium; ezetimibe TABLET;ORAL 206084-002 Apr 26, 2017 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

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 020702-004 Apr 7, 2000 ⤷  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
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 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

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

Supplementary Protection Certificates for atorvastatin calcium

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 92545 Luxembourg ⤷  Try a Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0247633 C970034 Netherlands ⤷  Try a Trial 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
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
1003503 05C0048 France ⤷  Try a Trial 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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