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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atorvastatin calcium; ezetimibe has sixty-four patent family members in thirty-six countries.

There are sixty drug master file entries for atorvastatin calcium; ezetimibe.

Summary for Generic Name: atorvastatin calcium; ezetimibe

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list60
Clinical Trials: see list2,523
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;ORAL200153-004May 3, 2013DISCNYesNo5,969,156*PED► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNYesNoRE42461*PED► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNYesNo5,969,156*PED► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNo5,969,156*PED► SubscribeY► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013DISCNYesNoRE42461*PED► 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;ORAL200153-001May 3, 2013RE42461*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 20135,969,156*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013RE42461*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 20135,686,104*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 20135,969,156*PED► Subscribe
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International Patent Family for Ingredient: atorvastatin calcium; ezetimibe

Country Document Number Estimated Expiration
Israel122118► Subscribe
European Patent Office1148049► Subscribe
Argentina003458► Subscribe
Slovenia1148049► Subscribe
Spain2167587► 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
/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
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Cipla
Johnson and Johnson
US Army
Daiichi Sankyo
Boehringer Ingelheim
Julphar
Baxter
McKinsey

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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