DrugPatentWatch Database Preview
LIPITOR Drug Profile
» See Plans and Pricing
When do Lipitor patents expire, 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. Fifty-three suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
US ANDA 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 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 195 |
| Patent Applications: | 4,471 |
| 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 |
|---|---|
| Amgen | Phase 4 |
| Brigham and Women's Hospital | Phase 4 |
| Wake Forest University Health Sciences | Phase 4 |
Pharmacology for LIPITOR
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Paragraph IV (Patent) Challenges for LIPITOR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LIPITOR | TABLET;ORAL | atorvastatin calcium | 020702 |
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 | Start Trial | Start Trial | Start Trial | |||
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | AB | RX | Yes | No | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | Start Trial | Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LIPITOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2002234871 | Start Trial |
| Cyprus | 2357 | Start Trial |
| Slovenia | 1148049 | Start Trial |
| Japan | 2014051533 | Start Trial |
| Japan | S62289577 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LIPITOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | CR 2014 00050 | Denmark | Start Trial | PRODUCT 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 |
| 0247633 | 97C0118 | France | Start Trial | PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107 |
| 0247633 | SPC/GB97/011 | United Kingdom | Start Trial | SPC/GB97/011: 20070529, EXPIRES: 20111106 |
| 1003503 | SZ 30/2006 | Austria | Start Trial | PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN |
| 0247633 | 97C0103 | Belgium | Start Trial | PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
