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Atorvastatin calcium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for atorvastatin calcium?

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:3
Applicants:11
NDAs:12
Drug Master File Entries: see list60
Suppliers / Packagers: see list56
Bulk Api Vendors: see list126
Clinical Trials: see list973
Patent Applications: see list6,572
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
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNoRE42461*PED► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNo5,969,156*PED► SubscribeY► Subscribe
Kremers Urban Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL091624-001Apr 5, 2013RXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL091650-002Jul 17, 2012RXNoNo► Subscribe► Subscribe
Sandoz Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL077575-003May 29, 2012RXNoNo► Subscribe► 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;ORAL020702-002Dec 17, 19964,681,893*PED► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 20005,686,104*PED► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 20005,969,166► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 19964,681,893*PED► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-003Dec 17, 19966,126,971*PED► Subscribe
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International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
Hungary9900678► Subscribe
Japan2011195592► Subscribe
Poland193479► Subscribe
Romania120070► Subscribe
Bulgaria63630► 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
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
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
545Luxembourg► SubscribePRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
C0048France► SubscribePRODUCT 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
/2006Austria► SubscribePRODUCT 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
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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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