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Pfizer Company Profile

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What is the competitive landscape for PFIZER, and when can generic versions of PFIZER drugs launch?

PFIZER has one hundred and thirty-five approved drugs.

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

There are seven hundred and seventy patent family members on PFIZER drugs in seventy-one countries and one hundred and forty-seven supplementary protection certificates in seventeen countries.

Summary for Pfizer

International Patents:	770
US Patents:	37
Tradenames:	102
Ingredients:	96
NDAs:	135
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	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No	6,936,612		Y	Y
Pfizer	VIBRA-TABS	doxycycline hyclate	TABLET;ORAL	050533-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer Inc	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes
Pfizer	VISTARIL	hydroxyzine hydrochloride	INJECTABLE;INJECTION	011111-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	TERRAMYCIN	oxytetracycline	TABLET;ORAL	050287-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GEODON	ziprasidone mesylate	INJECTABLE;INTRAMUSCULAR	020919-001	Jun 21, 2002	6,399,777
Pfizer Inc	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	6,469,012*PED
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-001	Approved Prior to Jan 1, 1982	3,644,627
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997	5,602,133
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004	5,273,995*PED

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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	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
	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
	Sublingual Tablets	0.6 mg		2011-12-29
	Capsules	5 mg and 10 mg		2005-06-21
	For Injection	500 mg/vial		2011-06-17
	Extended-release Tablets	4 mg and 8 mg		2012-10-31
	Tablets	5 mg/80 mg		2009-04-07
	Capsules	75 mg, 100 mg and 125 mg		2019-02-04

International Patents for Pfizer Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0307057
World Intellectual Property Organization (WIPO)	0142246
El Salvador	2004001459
Taiwan	I228043
Israel	211070

Supplementary Protection Certificates for Pfizer Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	132017000095300	Italy		PRODUCT NAME: TOFACITINIB, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRENDENTE IL SALE CITRATO(XELJANZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1178/001-004, 20170324
1481964	C 2007 098	Romania		PRODUCT NAME: FUMARATACID DE FESOTERODINA IN FORMA CRISTALINA 2[(1R)-3-(DIIZOPROPILAMINO)-1-FENILPROPIL]-4-(HIDROXIMETIL)FENILIZOBUTIRIC INFORMA CRISTALINA - FUMARAT ACID DE FESOTERODINA IN FORMA CRISTALINA; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/386/001, RO EU/1/07/386/002, RO EU/1/07/386/003, RO EU/1/07/386/004, RO EU/1/07/386/005, RO EU/1/07/386/006, RO EU/1/07/386/007, RO EU/1/07/386/008, RO EU/1/07/386/009, RO EU/1/07/386/010; DATE OF NATIONAL AUTHORISATION: 20070420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/386/001, EU/1/07/386/002, EU/1/07/386/003, EU/1/07/386/004, EU/1/07/386/005, EU/1/07/386/006, EU/1/07/386/007, EU/1/07/386/0 [...]
1230209	PA2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1470124	132017000046148	Italy		PRODUCT NAME: PALBOCICLIB, OPZIONALMENTE NELLA FORMA DI UN SALE, ESTERE, AMMIDE O PROFARMACO FARMACEUTICAMENTE ACCETTABILE(IBRANCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1147/001-006, 20161111
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112

Similar Applicant Names

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

• Pfizer
• Pfizer Global
• Pfizer Inc
• Pfizer Ireland
• Pfizer Labs