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Atorvastatin calcium; ezetimibe - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for atorvastatin calcium; ezetimibe?

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

This ingredient has sixty-four patent family members in thirty-six countries.

There are sixty drug master file entries for atorvastatin calcium; ezetimibe. One supplier is listed for this compound.

Summary for Generic Name: atorvastatin calcium; ezetimibe

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list60
Suppliers / Packagers: see list1
Clinical Trials: see list1,041
Drug Prices:see low prices
DailyMed Link:atorvastatin calcium; ezetimibe at DailyMed

Pharmacology for Ingredient: atorvastatin calcium; ezetimibe

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 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;ORAL200153-002May 3, 2013DISCNYesNoRE42461*PED► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 2013DISCNYesNoRE42461*PED► Subscribe ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNo5,969,156*PED► SubscribeY► 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, 20135,846,966*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 20135,686,104*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;ORAL200153-002May 3, 20135,846,966*PED► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 20135,846,966*PED► Subscribe
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International Patent Family for Ingredient: atorvastatin calcium; ezetimibe

Country Document Number Estimated Expiration
Norway309898► Subscribe
Australia725424► Subscribe
Poland193479► Subscribe
Israel128864► Subscribe
South Korea100389518► 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
/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
C0103Belgium► SubscribePRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
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
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