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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 fifty-three approved drugs.

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

There are one thousand three hundred and eighty patent family members on PFIZER drugs in seventy-nine countries and one hundred and forty-six supplementary protection certificates in fourteen countries.

Summary for Pfizer

International Patents:	1380
US Patents:	50
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	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	AB2	RX	Yes	Yes
Pfizer Pharms	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993	AB	RX	Yes	No
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-003	Jan 29, 1990	AB	RX	Yes	Yes
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	EXUBERA	insulin recombinant human	POWDER;INHALATION	021868-001	Jan 27, 2006		DISCN	No	No	6,546,929

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	4,765,989
Pfizer	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	4,831,031
Pfizer Pharms	NEURONTIN	gabapentin	TABLET;ORAL	020882-002	Oct 9, 1998	5,084,479*PED
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	6,124,363
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-010	Jul 29, 2004	5,969,156*PED

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

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
Eurasian Patent Organization	002869
Norway	323378
New Zealand	332480
African Intellectual Property Organization (OAPI)	12612
Canada	2389749

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2017	Austria		PRODUCT NAME: INSULIN GLARGIN UND LIXISENATID; REGISTRATION NO/DATE: EU/1/16/1157 (MITTEILUNG) 20170113
0883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
90029-5	Sweden		PRODUCT NAME: INSULIN DEGLUDEK
0885	Netherlands		PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
253	Luxembourg		91253, EXPIRES: 20200707

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