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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	ELELYSO	taliglucerase alfa	POWDER;INTRAVENOUS	022458-001	May 1, 2012		RX	Yes	Yes	8,741,620		Y	Y
Pfizer	CEFOBID	cefoperazone sodium	INJECTABLE;INJECTION	063333-002	Mar 31, 1995		DISCN	No	No
Pfizer	CALAN SR	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019152-002	Dec 15, 1989		DISCN	Yes	No
Pfizer	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-001	Dec 21, 2011		OTC	Yes	Yes
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer Inc	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-002	May 1, 2007		DISCN	No	No

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	3,862,319
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-004	Jan 30, 2004	5,273,995*PED
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	4,783,337
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	4,612,008
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-005	Jan 30, 2004	6,126,971*PED
Pfizer Pharms	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000	6,500,456

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

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
Austria	A904399
Hong Kong	1070653
Eurasian Patent Organization	199900467
China	1154494
Portugal	1690536
Panama	8507301

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB01/023	United Kingdom		PRODUCT NAME: ELETRIPTAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE HYDROBROMIDE SALT; REGISTERED: CH 55218 01 20001214; CH 52218 02 20001214; CH 52218 03 20001214; UK PL 00057/0452 20010212; UK PL 00057/0453 20010212; UK PL 00057/0454 20010212
90042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
90067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2017020,C2498802	Lithuania		PRODUCT NAME: INSULINAS GLARGINAS + LIKSISENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912

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