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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-two 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	PFIZERPEN VK	penicillin v potassium	FOR SOLUTION;ORAL	061815-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MODERIL	rescinnamine	TABLET;ORAL	010686-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016		DISCN	No	No
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	AB2	RX	Yes	Yes

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,591,584
Pfizer Inc	CAMPTOSAR	irinotecan hydrochloride	INJECTABLE;INJECTION	020571-001	Jun 14, 1996	4,604,463*PED
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-005	Jan 30, 2004	4,572,909*PED
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997	6,046,202

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	0.125 mg, 0.25 mg, and 0.5 mg		2014-05-01
	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
	Capsules	200 mg/38 mg		2016-02-16
	Capsules	200 mg/30 mg		2004-12-27
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg		2005-10-19
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Tablets	25 mg and 50 mg		2004-11-19
	Capsules	5 mg and 10 mg		2005-06-21
	Tablets	2.5 mg/40 mg		2009-09-17
	For Injection	500 mg/vial		2011-06-17
	Extended-release Tablets	4 mg and 8 mg		2012-10-31
	Extended-release Tablets	11 mg		2016-11-07
	Tablets	5 mg/80 mg		2009-04-07
	Extended-release Tablets	330 mg		2018-01-29
	Injection	20 mg/mL, 2 mL and 5 mL vials		2004-07-26
	Extended-release Tablets	330 mg		2018-01-29
	Tablets	150 mg and 200 mg		2005-11-09
	Tablets	100 mg		2004-10-25
	Capsules	20 mg, 40 mg, 60 mg and 80 mg		2005-02-07
	Tablets	20 mg and 40 mg		2010-03-29
	Sublingual Tablets	0.6 mg		2011-12-29

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
9,180,100	Methylphenidate extended release chewable tablet
5,684,189	GABA and L-glutamic acid analogs for antiseizure treatment
6,138,668	Method and device for delivering aerosolized medicaments
7,842,699	Pyrrolo[2,3-D]pyrimidine compounds

International Patents for Pfizer Drugs

Country	Document Number	Estimated Expiration
Austria	220056
Germany	60001649
South Africa	9807844
Argentina	015553

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
60026	Netherlands		PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
0885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0023	Belgium		PRODUCT NAME: MEROPENEM TRIHYDR; NAT. REGISTRATION NO/DATE: 624 IS 88 F 12 19960205; FIRST REGISTRATION: IT 028949028 19940817

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