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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, Apotex Inc, Dr Reddys Labs Ltd, Teva Pharms, Sandoz Inc, Sun Pharm Inds Ltd, and Merck Sharp Dohme, and is included in eleven 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. Forty-nine suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

Tradenames:3
Patents:2
Applicants:10
NDAs:11
Drug Master File Entries: see list60
Suppliers / Packaging: see list49
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: atorvastatin calcium

Clinical Trials for: atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL205519-002May 19, 2016RXNo
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNNo5,969,156*PEDJan 8, 2017Y
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNNoMay 3, 2016
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Expired Orange Book Patents for Generic Ingredient: atorvastatin calcium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 19966,126,971*PED<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-003Dec 17, 1996RE40667*PED<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 1996RE40667*PED<disabled>
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International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
Australia6484296<disabled in preview>
Hungary9900678<disabled in preview>
Slovakia284202<disabled in preview>
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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
1003503/01Switzerland<disabled>PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
C0048France<disabled>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
70034Netherlands<disabled>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
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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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