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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-five approved drugs.

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

There are one thousand four hundred and thirty-six patent family members on PFIZER drugs in eighty countries and one hundred and seventy supplementary protection certificates in sixteen countries.

Summary for Pfizer

International Patents:	1436
US Patents:	51
Tradenames:	122
Ingredients:	108
NDAs:	155
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	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	AB	RX	Yes	No
Pfizer	TROBICIN	spectinomycin hydrochloride	INJECTABLE;INJECTION	050347-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	PFIZERPEN G	penicillin g potassium	TABLET;ORAL	060075-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	TERRAMYCIN-POLYMYXIN	oxytetracycline hydrochloride; polymyxin b sulfate	TABLET;VAGINAL	061009-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	DARICON	oxyphencyclimine hydrochloride	TABLET;ORAL	011612-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Inc	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No	8,685,443

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	4,087,544*PED
Pfizer Pharms	ACCUPRIL	quinapril hydrochloride	TABLET;ORAL	019885-003	Nov 19, 1991	5,747,504*PED
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992	4,327,725
Pfizer	GEODON	ziprasidone mesylate	INJECTABLE;INTRAMUSCULAR	020919-001	Jun 21, 2002	5,376,645
Pfizer	EXUBERA	insulin recombinant human	POWDER;INHALATION	021868-001	Jan 27, 2006	6,592,904
Pfizer	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-002	Dec 30, 1991	5,789,449

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg		2005-10-19
	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
	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/38 mg		2016-02-16
	Sublingual Tablets	0.6 mg		2011-12-29
	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
	Capsules	75 mg, 100 mg and 125 mg		2019-02-04
	Extended-release Tablets	11 mg		2016-11-07
	Tablets	100 mg		2004-10-25
	Capsules	200 mg/30 mg		2004-12-27

Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for Pfizer Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2036541
Canada	2448281
European Patent Office	3241832
Australia	2002304401
South Korea	100366167
Japan	H10501519

Supplementary Protection Certificates for Pfizer Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	07C0050	France		PRODUCT NAME: FESOTERODINE ET SES SELS AVEC DES ACIDES PHYSIOLOGIQUEMENT ACCEPTABLES NOTAMMENT L ACIDE FUMARIQUE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/386/001 DU 20070420; REGISTRATION NO/DATE AT EEC: EU/1/07/386/001 DU 20070420
2340033	300880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
2498802	C201730022	Spain		PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111
0792290	04C0020	France		PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)

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