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Pfizer Company Profile

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What is the competitive landscape for PFIZER, and what generic alternatives to PFIZER drugs are available?

PFIZER has one hundred and fifty-five approved drugs.

There are fifty-one US patents protecting PFIZER drugs. There is one tentative approval on PFIZER drugs.

There are one thousand four hundred and twenty-five patent family members on PFIZER drugs in eighty countries and one hundred and forty-six supplementary protection certificates in fourteen countries.

Summary for Pfizer

International Patents:	1425
US Patents:	51
Tradenames:	122
Ingredients:	108
NDAs:	155
Drug Master File Entries:	3
Patent Litigation for Pfizer:	See patent lawsuits for Pfizer
PTAB Cases with Pfizer as petitioner:	See PTAB cases with Pfizer as petitioner

Drugs and US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes	8,680,111		Y	Y
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006		DISCN	No	No	6,150,366		Y
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	REVATIO	sildenafil citrate	FOR SUSPENSION;ORAL	203109-001	Aug 30, 2012		RX	Yes	Yes
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	AB	RX	Yes	No	6,455,574
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No
Pfizer	ELELYSO	taliglucerase alfa	POWDER;INTRAVENOUS	022458-001	May 1, 2012		RX	Yes	Yes	8,790,641

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Inc	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998	4,303,651
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	5,969,156*PED
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990	4,404,216*PED
Pfizer	VANSIL	oxamniquine	CAPSULE;ORAL	018069-001	Approved Prior to Jan 1, 1982	3,903,283
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996	6,268,489
Pfizer	GEODON	ziprasidone mesylate	INJECTABLE;INTRAMUSCULAR	020919-001	Jun 21, 2002	6,110,918
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	4,681,893*PED

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	4 mg and 8 mg		2012-10-31
	Tablets	5 mg/80 mg		2009-04-07
	Injection	20 mg/mL, 2 mL and 5 mL vials		2004-07-26
	Tablets	25 mg and 50 mg		2004-11-19
	Tablets	20 mg and 40 mg		2010-03-29
	Capsules	200 mg/30 mg		2004-12-27
	Sublingual Tablets	0.6 mg		2011-12-29
	Capsules	20 mg, 40 mg, 60 mg and 80 mg		2005-02-07
	Capsules	0.125 mg, 0.25 mg, and 0.5 mg		2014-05-01
	Tablets	150 mg and 200 mg		2005-11-09
	Tablets	5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg		2006-12-29
	Tablets	2.5 mg/40 mg		2009-09-17
	Extended-release Tablets	11 mg		2016-11-07
	Tablets	100 mg		2004-10-25
	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg		2005-10-19
	Capsules	200 mg/38 mg		2016-02-16
	Capsules	5 mg and 10 mg		2005-06-21
	For Injection	500 mg/vial		2011-06-17

Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for Pfizer Drugs

Country	Document Number	Estimated Expiration
China	102240397
Czech Republic	20000511
China	1184962
Mexico	9603936
Poland	1746999
Japan	2002527385
South Africa	9807844

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB97/084	United Kingdom		PRODUCT NAME: TROGLITAZONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 10949/0277 19970729; UK 10949/0278 19970729; UK 10949/0279 19970729; UK 06384/0005 19970729; UK 06384/0006 19970729; UK 06384/0007 19970729
C/GB97/010	United Kingdom		PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
2107069/01	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C/GB98/045	United Kingdom		PRODUCT NAME: TROVAFLOXACIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE MESYLATE SALT.; REGISTERED: CH 54483 19980327; UK EU/1/98/059/001 19980703; UK EU/1/98/059/002 19980703; UK EU/1/98/059/003 19980703; UK EU/1/98/059/004 19980703; UK EU/1/98/059/005 19980703; UK EU/1/98/059/006 19980703; UK EU/1/98/059/007 19980703; UK EU/1/98/059/008 19980703; UK EU/1/98/059/009 19980703; UK EU/1/98/059/010 19980703; UK EU/1/98/059/011 19980703; UK EU/1/98/059/012 19980703
00698	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
0885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Pfizer
• Pfizer Cons Hlthcare
• Pfizer Global
• Pfizer Inc
• Pfizer Ireland
• Pfizer Labs
• Pfizer Pharms