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

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

Summary for Pfizer

International Patents:	1281
US Patents:	48
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	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	MINIPRESS XL	prazosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019775-002	Jan 29, 1992		DISCN	No	No
Pfizer	EXUBERA	insulin recombinant human	POWDER;INHALATION	021868-001	Jan 27, 2006		DISCN	No	No	6,582,728		Y
Pfizer	URESE	benzthiazide	TABLET;ORAL	012128-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	PFIZERPEN-A	ampicillin/ampicillin trihydrate	FOR SUSPENSION;ORAL	062049-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Inc	LORBRENA	lorlatinib	TABLET;ORAL	210868-002	Nov 2, 2018		RX	Yes	Yes	8,680,111		Y	Y
Pfizer	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	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	020720-001	Jan 29, 1997	6,046,202
Pfizer	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	5,744,501
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	4,959,366
Pfizer	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996	4,536,518*PED
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-001	Apr 26, 1994	5,082,668
Pfizer	EXUBERA	insulin recombinant human	POWDER;INHALATION	021868-002	Jan 27, 2006	6,737,045
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006	4,831,031

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	100 mg		2004-10-25
	Capsules	200 mg/30 mg		2004-12-27
	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

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
Argentina	037635
Luxembourg	90687
Bulgaria	66489
Russian Federation	2535342
African Intellectual Property Organization (OAPI)	12118
Mexico	PA00011096
Japan	4386936

Supplementary Protection Certificates for Pfizer Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2597103	19/2017	Austria		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUTEC UND LIRAGLUTID; NAT. REGISTRATION NO/DATE: EU/1/14/947/001-4 20140918; FIRST REGISTRATION: LI 65041 (CH) 20140912
2340033	2017C/024	Belgium		PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
2498802	122017000039	Germany		PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
2107069	C02107069/02	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
1666481	1790038-2	Sweden		PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REG. NO/DATE: EU/1/17/1178 20170324

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
• Pfizer Pharms