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Atorvastatin calcium - Generic Drug Details

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Atorvastatin calcium is the generic ingredient in three branded drugs marketed by Pfizer, Sciegen Pharms Inc, Kremers Urban Pharms, Mylan Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Teva Pharms, Sandoz Inc, Sun Pharm Inds Ltd, and Merck Sharp Dohme, and is included in eleven NDAs. 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. Forty-nine suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

Tradenames:3
Patents:2
Applicants:10
NDAs:11
Drug Master File Entries: see list60
Suppliers / Packaging: see list49
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: atorvastatin calcium

Clinical Trials for: atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL078773-003May 29, 2012DISCNNo<disabled><disabled>
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013DISCNNo<disabled><disabled>
Teva Pharms
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL078773-004May 29, 2012DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: atorvastatin calcium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 19966,126,971*PED<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-003Dec 17, 19965,385,929<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 19965,273,995*PED<disabled>
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International Patent Family for Ingredient: atorvastatin calcium

Country Document Number Estimated Expiration
Eurasian Patent Organization000474<disabled in preview>
New Zealand312907<disabled in preview>
Slovenia1148049<disabled in preview>
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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
1003503/01Switzerland<disabled>PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
70034Netherlands<disabled>PRODUCT 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
C0103Belgium<disabled>PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
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