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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-three approved drugs.

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

There are one thousand four hundred and one patent family members on PFIZER drugs in seventy-nine countries and one hundred and fifty-eight supplementary protection certificates in fourteen countries.

Summary for Pfizer

International Patents:	1401
US Patents:	54
Tradenames:	120
Ingredients:	106
NDAs:	153
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 VK	penicillin v potassium	FOR SOLUTION;ORAL	061815-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	201370-002	Jul 21, 2011		RX	Yes	Yes
Pfizer	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	AB	RX	Yes	No	6,455,574
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No	8,338,478		Y	Y
Pfizer	PENICILLIN G PROCAINE	penicillin g procaine	INJECTABLE;INJECTION	060099-001	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	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991	4,962,128*PED
Pfizer	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	5,312,925
Pfizer	EXUBERA	insulin recombinant human	POWDER;INHALATION	021868-002	Jan 27, 2006	6,737,045
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	5,091,190
Pfizer	SINEQUAN	doxepin hydrochloride	CONCENTRATE;ORAL	017516-001	Approved Prior to Jan 1, 1982	3,420,851

Paragraph IV (Patent) Challenges for PFIZER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02
	Capsules	200 mg/30 mg		2004-12-27
	Tablets	25 mg and 50 mg		2004-11-19
	Capsules	20 mg, 40 mg, 60 mg and 80 mg		2005-02-07
	Tablets	20 mg and 40 mg		2010-03-29
	Capsules	0.125 mg, 0.25 mg, and 0.5 mg		2014-05-01
	Sublingual Tablets	0.6 mg		2011-12-29
	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	330 mg		2018-01-29
	Extended-release Tablets	330 mg		2018-01-29
	Extended-release Tablets	11 mg		2016-11-07
	Capsules	200 mg/38 mg		2016-02-16
	Tablets	100 mg		2004-10-25
	Capsules	5 mg and 10 mg		2005-06-21
	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg		2005-10-19
	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
	Extended-release Tablets	82.5 mg and 165 mg		2018-02-02

Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for Pfizer

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,842,699	Pyrrolo[2,3-D]pyrimidine compounds
6,262,120	GABA and L-glutamic acid analogs for antiseizure treatment
7,601,727	Pyrrolo[2,3-d]pyrimidine compounds
8,337,890	Modified release formulations containing drug-ion exchange resin complexes
9,549,989	Modified release formulations containing drug-ion exchange resin complexes

International Patents for Pfizer Drugs

Country	Document Number	Estimated Expiration
Argentina	015553
China	1690041
Portugal	2333083
World Intellectual Property Organization (WIPO)	02096909
Czech Republic	9602600

Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
172	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)
00596	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
365	Luxembourg		91365, EXPIRES: 20220420

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