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Generated: July 21, 2017
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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 3 |
| Applicants: | 13 |
| NDAs: | 14 |
| Drug Master File Entries: see list | 61 |
| Suppliers / Packagers: see list | 57 |
| Bulk Api Vendors: see list | 126 |
| Clinical Trials: see list | 2,363 |
| Patent Applications: see list | 7,427 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | atorvastatin calcium at DailyMed |
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 078773-002 | May 29, 2012 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Teva Pharms Usa | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 205300-002 | Mar 27, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Pharms Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 091226-002 | May 29, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 078773-003 | May 29, 2012 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Sciegen Pharms Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 205519-004 | May 19, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | 5,969,156*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | 6,126,971*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | 5,969,156*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | 5,273,995*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | 6,126,971*PED | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2167587 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 003459 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 294695 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 309898 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2233526 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0118 | France | ► Subscribe | PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107 | ||||||||||||||||||||||||||
| /2006 | Austria | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| C0048 | France | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| 70034 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 545 | Luxembourg | ► Subscribe | PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910 | ||||||||||||||||||||||||||
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