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Atorvastatin calcium - Generic Drug Details

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Atorvastatin calcium is the generic ingredient in three branded drugs marketed by Pfizer, Sciegen Pharms Inc, Kremers Urban Pharms, Mylan Pharms Inc, Invagen Pharms, Apotex Inc, Dr Reddys Labs Ltd, Teva Pharms, Sandoz Inc, Sun Pharm Inds Ltd, and Merck Sharp Dohme, and is included in twelve NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in thirty-six countries.

There are sixty drug master file entries for atorvastatin calcium. Fifty-six suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

Tradenames:3
Patents:2
Applicants:11
NDAs:12
Drug Master File Entries: see list60
Suppliers / Packagers: see list56
Bulk Api Vendors: see list126
Clinical Trials: see list971
Patent Applications: see list13,226
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:atorvastatin calcium at DailyMed

Pharmacology for Ingredient: atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL076477-004Nov 30, 2011RXNoNo► subscribe► subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNYesNo5,969,156*PED► subscribeY► subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 2000RXYesYes5,969,156*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 20006,126,971*PED► subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 1996RE40667*PED► subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-003Dec 17, 19965,686,104*PED► subscribe
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International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
Austria284868► subscribe
South Africa9606044► subscribe
Argentina003458► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ATORVASTATIN CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/1997Austria► subscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
70034Netherlands► subscribePRODUCT 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
2014 00050Denmark► subscribePRODUCT 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
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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 verifification 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.

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