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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-three approved drugs.

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

There are one thousand four hundred and one patent family members on PFIZER drugs in seventy-nine countries and one hundred and fifty-eight supplementary protection certificates in fourteen countries.

Summary for Pfizer

International Patents:	1401
US Patents:	54
Tradenames:	120
Ingredients:	106
NDAs:	153
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	NAVANE	thiothixene hydrochloride	INJECTABLE;INJECTION	016904-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	ZITHROMAX	azithromycin	CAPSULE;ORAL	050670-001	Nov 1, 1991		DISCN	Yes	No
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-001	Nov 19, 1991	AB	RX	Yes	No
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	AB	RX	Yes	Yes
Pfizer	TETRACYN	procaine hydrochloride; tetracycline hydrochloride	INJECTABLE;INJECTION	060285-002	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	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-002	Dec 30, 1991	4,962,128*PED
Pfizer	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	5,312,925
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997	5,478,852
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,674,876
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	6,455,574
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004	5,686,104*PED

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Capsules	200 mg/30 mg		2004-12-27
	Tablets	25 mg and 50 mg		2004-11-19
	Capsules	20 mg, 40 mg, 60 mg and 80 mg		2005-02-07
	Tablets	20 mg and 40 mg		2010-03-29
	Capsules	0.125 mg, 0.25 mg, and 0.5 mg		2014-05-01
	Sublingual Tablets	0.6 mg		2011-12-29
	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	330 mg		2018-01-29
	Extended-release Tablets	330 mg		2018-01-29
	Extended-release Tablets	11 mg		2016-11-07
	Capsules	200 mg/38 mg		2016-02-16
	Tablets	100 mg		2004-10-25
	Capsules	5 mg and 10 mg		2005-06-21
	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg		2005-10-19
	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
	Injection	20 mg/mL, 2 mL and 5 mL vials		2004-07-26
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02

Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for Pfizer

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,231,851	Methods and compositions for the dry powder formulation of interferons
5,847,151	Gaba and L-glutamic acid analogs for antiseizure treatment
7,951,557	Human lysosomal proteins from plant cell culture
8,685,444	Sequestering subunit and related compositions and methods
8,883,217	Modified release formulations containing drug-ion exchange resin complexes
7,842,699	Pyrrolo[2,3-D]pyrimidine compounds

International Patents for Pfizer Drugs

Country	Document Number	Estimated Expiration
Japan	3441676
Spain	2200184
Turkey	200001135
China	1184962
Japan	2001518500
South Korea	100563149

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
1235830/01	Switzerland		PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
00486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
/2001	Austria		PRODUCT NAME: ELETRIPTAN UND DIE PHARMAZEUTISCH VERTRAEGLICHEN SALZE DAVON, EINSCHLIESSLICH DES HYDROBROMIDS; NAT. REGISTRATION NO/DATE: 1-24155 20010801; FIRST REGISTRATION: LI 55218 01, 55218 02 20001214
C/GB07/053	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/053 GRANTED TO SCHWARZ PHARMA AG IN RESPECT OF THE PRODUCT FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6299 DATED 10 FEBRUARY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23 APRIL 2022.
80045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204

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