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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 ninety-two approved drugs.

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

There are seven hundred patent family members on PFIZER drugs in sixty-six countries and two hundred and five supplementary protection certificates in nineteen countries.

Summary for Pfizer

International Patents:	700
US Patents:	32
Tradenames:	156
Ingredients:	126
NDAs:	192
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	penicillin g potassium	INJECTABLE;INJECTION	060657-003	Approved Prior to Jan 1, 1982	AP	RX	No	Yes
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-002	May 1, 2007		DISCN	No	No
Pfizer	PFIZERPEN-A	ampicillin/ampicillin trihydrate	CAPSULE;ORAL	062050-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes
Pfizer	TERRAMYCIN-POLYMYXIN	oxytetracycline hydrochloride; polymyxin b sulfate	TABLET;VAGINAL	061009-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	PROVERA	medroxyprogesterone acetate	TABLET;ORAL	011839-004	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for Pfizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997	5,859,037
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	4,100,347
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997	5,457,109
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	5,232,705
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	3,862,319
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	3,426,067

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	75 mg/0.2 mg		2008-11-28
	Extended-release Tablets	330 mg		2018-01-29
	Extended-release Tablets	330 mg		2018-01-29
	Capsules	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg		2008-12-30
	Extended-release Tablets	4 mg and 8 mg		2012-10-31
	Capsules	5 mg and 10 mg		2005-06-21
	Injection	20 mg/mL, 2 mL and 5 mL vials		2004-07-26
	For Injection	500 mg/vial		2011-06-17
	Oral Suspension	100 mg/5 mL		2009-08-03
	Injection	2 mg/mL, 100 mL bag		2009-12-29
	Tablets	5 mg		2016-11-07
	Delayed-release Tablets	50 mg/0.2 mg		2009-06-29
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Capsules	75 mg, 100 mg and 125 mg		2019-02-04
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Oral Solution	20 mg/mL		2010-05-19
	Extended-release Tablets	11 mg		2016-11-07
	Capsules	0.125 mg, 0.25 mg, and 0.5 mg		2014-05-01
	Capsules	20 mg, 40 mg, 60 mg and 80 mg		2005-02-07
	Tablets	600 mg		2005-12-21
	Injection	2 mg/mL, 300 mL bag		2009-09-01
	Tablets	1 g		2005-08-23

International Patents for Pfizer Drugs

Country	Patent Number	Estimated Expiration
Germany	60136341
Argentina	048652
Poland	218519
Argentina	104391
Chile	2014002084
African Regional IP Organization (ARIPO)	2377

Supplementary Protection Certificates for Pfizer Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	300863	Netherlands		PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
1481964	C 2007 098	Romania		PRODUCT NAME: FUMARATACID DE FESOTERODINA IN FORMA CRISTALINA 2[(1R)-3-(DIIZOPROPILAMINO)-1-FENILPROPIL]-4-(HIDROXIMETIL)FENILIZOBUTIRIC INFORMA CRISTALINA - FUMARAT ACID DE FESOTERODINA IN FORMA CRISTALINA; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/386/001, RO EU/1/07/386/002, RO EU/1/07/386/003, RO EU/1/07/386/004, RO EU/1/07/386/005, RO EU/1/07/386/006, RO EU/1/07/386/007, RO EU/1/07/386/008, RO EU/1/07/386/009, RO EU/1/07/386/010; DATE OF NATIONAL AUTHORISATION: 20070420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/386/001, EU/1/07/386/002, EU/1/07/386/003, EU/1/07/386/004, EU/1/07/386/005, EU/1/07/386/006, EU/1/07/386/007, EU/1/07/386/0 [...]
2603514	2019/018	Ireland		PRODUCT NAME: A COMBINATION OF VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE; REGISTRATION NO/DATE: EU/1/18/1334 20181120

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Pfizer
• Pfizer Global
• Pfizer Inc
• Pfizer Labs
• Pfizer Pharms