LIPITOR Drug Patent Profile

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-nine 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 30^th, 2011.

Summary for LIPITOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	228
Patent Applications:	4,956
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

See drug prices for LIPITOR

See drug sales revenues for LIPITOR

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

See all LIPITOR clinical trials

Pharmacology for LIPITOR

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LIPITOR

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	AB	RX	Yes	Yes
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	AB	RX	Yes	No
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	AB	RX	Yes	No

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
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996
Upjohn	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996

International Patents for LIPITOR

See the table below for patents covering LIPITOR around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	100389518
Spain	2233526
Ireland	871197
Spain	2167587
Romania	120070	FORME CRISTALINE ALE SĂRII SEMICALCICE A ACIDULUI| [(R-(R*, R*)]-2-(4-FLUOROFENIL)-BETA-DELTA-DIHIDROXI-5-(1-METILETIL)-3-FENIL-4-[(FENILAMINO)CARBONIL]-1H-PIROL-1-HEPTANOIC (ATORVASTATIN) (CRYSTALLINE FORMS OF [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 (ATORVASTATIN))

Supplementary Protection Certificates for LIPITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	05C0048	France		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
0247633	9790036	Sweden		PRODUCT NAME: ATORVASTIN OCH FARMACEUTISKT GODTAGBARA SALTER DäRAV; NAT. REGISTRATION NO/DATE: 13415 19970417; FIRST REG.: GB PL00018/0240 19961107
1003503	SZ 30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0247633	SPC/GB97/011	United Kingdom		SPC/GB97/011: 20070529, EXPIRES: 20111106
0720599	122014000088	Germany		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