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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-two approved drugs.

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

Summary for Pfizer

US Patents:	44
Tradenames:	119
Ingredients:	105
NDAs:	152
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	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TETRACYN	procaine hydrochloride; tetracycline hydrochloride	INJECTABLE;INJECTION	060285-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	AB	RX	Yes	No	6,150,366		Y
Pfizer	PENICILLIN G PROCAINE	penicillin g procaine	INJECTABLE;INJECTION	060099-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999	AB	RX	Yes	Yes
Pfizer	PFIZER-E	erythromycin stearate	TABLET;ORAL	061791-002	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	DIFLUCAN	fluconazole	TABLET;ORAL	019949-001	Jan 29, 1990	4,416,682
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-003	Aug 10, 1999	5,591,454
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	5,273,995*PED
Pfizer	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	4,536,518*PED
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	5,969,166
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	5,082,668

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

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
Norway	20063519
Czech Republic	9602600
Bulgaria	65367
Portugal	748213
Spain	2038756
Slovenia	0965343

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014000114	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
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
/2004	Austria		PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
0625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
213	Luxembourg		PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE

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