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.
Summary for atorvastatin calcium
International Patents: | 2 |
US Patents: | 2 |
Tradenames: | 5 |
Applicants: | 33 |
NDAs: | 34 |
Drug Master File Entries: | 55 |
Finished Product Suppliers / Packagers: | 62 |
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 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Laurus | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214513-003 | Jan 22, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sciegen Pharms Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 205519-001 | May 19, 2016 | 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 | |||
>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 | 020702-002 | 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 | 020702-004 | Apr 7, 2000 | ⤷ 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 |
---|---|---|---|
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
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
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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