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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Moodys
US Army
Julphar
Teva
Medtronic
Harvard Business School
Johnson and Johnson
Express Scripts

Generated: September 26, 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-four patent family members in thirty-six countries.

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

Summary for Generic Name: atorvastatin calcium

Tradenames:4
Patents:2
Applicants:13
NDAs:14
Drug Master File Entries: see list61
Suppliers / Packagers: see list58
Bulk Api Vendors: see list126
Clinical Trials: see list2,380
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
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL077575-003May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL076477-003Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Kremers Urban Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL091624-003Apr 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL077575-004May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sciegen Pharms Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL205519-002May 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL090548-003May 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL078773-004May 29, 2012DISCNNoNo► 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
Australia6484296► Subscribe
Hungary9900678► Subscribe
Slovakia284202► Subscribe
Portugal848705► Subscribe
Israel128862► Subscribe
Israel177377► Subscribe
Czech Republic294108► Subscribe
Estonia9800015► Subscribe
Peru1898► Subscribe
World Intellectual Property Organization (WIPO)9703959► 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
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
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
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
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
C0103Belgium► SubscribePRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
/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
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
/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 500+ biopharmaceutical companies globally:

Baxter
Federal Trade Commission
Queensland Health
US Army
Colorcon
QuintilesIMS
Daiichi Sankyo
Boehringer Ingelheim
Teva
Fuji

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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