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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 2017

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Atorvastatin calcium - Generic Drug Details

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What are the generic sources for atorvastatin calcium and what is the scope of atorvastatin calcium freedom to operate?

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

Atorvastatin calcium has sixty-nine patent family members in thirty-six countries and ten supplementary protection certificates in seven countries.

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

Pharmacology for atorvastatin calcium

Medical Subject Heading (MeSH) Categories 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
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-001Dec 17, 1996ABRXYesNo► Subscribe► SubscribeY► Subscribe
Teva PharmsATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL078773-004May 29, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL091226-002May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL091226-004May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-004Apr 7, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds LtdATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL076477-002Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen PharmsATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL204846-002Jan 9, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs TevaEZETIMIBE AND ATORVASTATIN CALCIUMatorvastatin calcium; ezetimibeTABLET;ORAL206084-003Apr 26, 2017RXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeLIPTRUZETatorvastatin calcium; ezetimibeTABLET;ORAL200153-002May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Teva PharmsATORVASTATIN CALCIUMatorvastatin calciumTABLET;ORAL078773-002May 29, 2012DISCNNoNo► Subscribe► 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
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-002Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-003Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-004Apr 7, 2000► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-004Apr 7, 2000► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-004Apr 7, 2000► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-001Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-003Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-001Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-003Dec 17, 1996► Subscribe► Subscribe
PfizerLIPITORatorvastatin calciumTABLET;ORAL020702-002Dec 17, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
Hungary9900678► Subscribe
Georgia, Republic ofP20002029► Subscribe
Czech Republic294695► Subscribe
Czech Republic9800121► Subscribe
South Korea100389518► Subscribe
Portugal1148049► Subscribe
European Patent Office0848705► Subscribe
South Africa9606044► Subscribe
Brazil9609872► Subscribe
Israel128865► 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
C0103Belgium► SubscribePRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
/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
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
C0118France► SubscribePRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
30/2006Austria► SubscribePRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
/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
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
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Chubb
Express Scripts
Harvard Business School
Fuji
Cipla
Farmers Insurance
Merck
Johnson and Johnson

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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