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Federal Trade Commission
Moodys
Medtronic
QuintilesIMS
Accenture
Citi
Julphar
Argus Health
Cerilliant
Fish and Richardson

Generated: October 17, 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 Teva Pharms Usa, 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, Merck Sharp Dohme, and Watson Labs Teva, 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. Fifty-nine suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

US Patents:2
Tradenames:4
Applicants:13
NDAs:14
Drug Master File Entries: see list61
Suppliers / Packagers: see list59
Bulk Api Vendors: see list126
Clinical Trials: see list2,385
Patent Applications: see list9,289
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL205519-003May 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL205300-003Mar 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL091226-001May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL076477-001Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL077575-003May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Teva Pharms Usa
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL205300-002Mar 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL204846-002Jan 9, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL204846-001Jan 9, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL076477-004Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: atorvastatin calcium

International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
South Korea100431038► Subscribe
China1087288► Subscribe
Austria208375► Subscribe
Norway980207► Subscribe
Czech Republic294740► Subscribe
Israel122118► Subscribe
Hungary9900678► Subscribe
Portugal848705► Subscribe
Romania120070► Subscribe
Israel177377► 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
C0103Belgium► SubscribePRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
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
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
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
30/2006Austria► SubscribePRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
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
/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
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Merck
Medtronic
Novartis
Express Scripts
Colorcon
McKinsey
McKesson
Deloitte
Mallinckrodt

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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