LIPITOR Drug Patent Profile
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Which patents cover Lipitor, and when can generic versions of Lipitor launch?
Lipitor is a drug marketed by Upjohn and is included in one NDA.
The generic ingredient in LIPITOR is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lipitor
A generic version of LIPITOR was approved as atorvastatin calcium by SUN PHARM INDS LTD on November 30th, 2011.
Summary for LIPITOR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 228 |
Patent Applications: | 4,406 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LIPITOR |
Drug Sales Revenues: | Drug sales revenues for LIPITOR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LIPITOR |
What excipients (inactive ingredients) are in LIPITOR? | LIPITOR excipients list |
DailyMed Link: | LIPITOR at DailyMed |
Recent Clinical Trials for LIPITOR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NYU Langone Health | Phase 4 |
Gannex Pharma Co., Ltd. | Phase 1 |
Montefiore Medical Center | N/A |
Pharmacology for LIPITOR
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LIPITOR
US Patents and Regulatory Information for LIPITOR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LIPITOR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LIPITOR
See the table below for patents covering LIPITOR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20030097628 | ⤷ Try a Trial | |
Austria | 208375 | ⤷ Try a Trial | |
Denmark | 1148049 | ⤷ Try a Trial | |
Estonia | 03606 | Kristalliline [R-(R*,R*)]-2-(4-fluorofenüül)-beeta, delta-dihüdroksü-5-(1-metüületüül)-3-fenüül-4-[(fenüülamino)karbonüül]-1H-pürrool-1-hept aanhappehemikaltsiumsool (atorvastatiin) | ⤷ Try a Trial |
Czech Republic | 294108 | Krystalická forma I hydrátu atorvastatinuŹ tj@ semivápenaté soli kyseliny [R@}RgŹRgB]@}@fluorfenylB@betaŹdelta@dihydroxy@Q@}�@methylethylB@fenyl[}fenylaminoBkarbonyl]@�H@pyrrol@�@heptanové (Crystalline form I of atorvastatin hydrate, i.e. [R-(R*,R*)]-2-(4-fluorophenyl)- beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt) | ⤷ Try a Trial |
Israel | 122118 | Crystalline form I atorvastatin pharmaceutical compositions containing it and process for its preparation | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LIPITOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1003503 | 30/2006 | Austria | ⤷ Try a Trial | 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 |
0720599 | 300689 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912 |
1003503 | 05C0048 | France | ⤷ Try a Trial | 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 |
0720599 | 122014000088 | Germany | ⤷ Try a Trial | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912 |
1003503 | C01003503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 |
0720599 | 92545 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |