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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
Cipla
Baxter
US Department of Justice
Dow
Citi
Cantor Fitzgerald
Johnson and Johnson
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Generated: October 21, 2017

DrugPatentWatch Database Preview

Atorvastatin calcium; ezetimibe - Generic Drug Details

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

Atorvastatin calcium; ezetimibe
is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme and Watson Labs Teva, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atorvastatin calcium; ezetimibe 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; ezetimibe.

Summary for Generic Name: atorvastatin calcium; ezetimibe

US Patents:2
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list61
Clinical Trials: see list2,570
Drug Prices:see low prices
DailyMed Link:atorvastatin calcium; ezetimibe at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Watson Labs Teva
EZETIMIBE AND ATORVASTATIN CALCIUM
atorvastatin calcium; ezetimibe
TABLET;ORAL206084-001Apr 26, 2017RXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Watson Labs Teva
EZETIMIBE AND ATORVASTATIN CALCIUM
atorvastatin calcium; ezetimibe
TABLET;ORAL206084-002Apr 26, 2017RXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Watson Labs Teva
EZETIMIBE AND ATORVASTATIN CALCIUM
atorvastatin calcium; ezetimibe
TABLET;ORAL206084-004Apr 26, 2017RXNoYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: atorvastatin calcium; ezetimibe

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013► Subscribe► Subscribe
This preview shows a limited data set
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Export unavailable in trial.
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International Patent Family for Ingredient: atorvastatin calcium; ezetimibe

Country Document Number Estimated Expiration
Canada2220018► Subscribe
Israel128862► Subscribe
Uruguay24985► Subscribe
Hungary223599► Subscribe
Portugal1148049► Subscribe
South Korea100389518► Subscribe
Spain2167587► Subscribe
Denmark1148049► Subscribe
Australia6484296► Subscribe
Poland324496► 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; EZETIMIBE

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
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
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
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
/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
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
/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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Fuji
McKinsey
QuintilesIMS
Teva
Medtronic
Daiichi Sankyo
Citi
Farmers Insurance
Chinese Patent Office

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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