LIPITOR Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Lipitor, and what generic alternatives are available?
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 | 020702-001 | 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 | 020702-003 | 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 | 020702-003 | Dec 17, 1996 | ⤷ 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 |
|---|---|---|---|
| Australia | 6484296 | ⤷ Try a Trial | |
| Mexico | 9709099 | SAL HEMI CALCIO DE ACIDO [R-R*,R*)]-2-(4-FLUOROFENIL)-BETA,DELTA-DIHIDROXI-5-(1-METIL ETIL)-3-FENIL-4-[(FENILAMINO)CARBONIL]-1H-PIRROLE-1-HEPTANOI CO (ATORVASTATIN). (CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-BETA,DELTA-DIHYDROXY-5-(1-MET HYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HE PTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN).) | ⤷ Try a Trial |
| Finland | 94339 | ⤷ Try a Trial | |
| Japan | H08505640 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 9703959 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 0247633 | 97C0103 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107 |
| 0720599 | CR 2014 00050 | Denmark | ⤷ Try a 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 | SPC/GB97/011 | United Kingdom | ⤷ Try a Trial | SPC/GB97/011: 20070529, EXPIRES: 20111106 |
| 0247633 | 97C0118 | France | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
