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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Federal Trade Commission
Covington
Cipla
US Department of Justice
McKesson
Accenture
Cantor Fitzgerald
US Army

Generated: October 22, 2017

DrugPatentWatch Database Preview

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-eight US patents protecting PFIZER drugs and there have been two Paragraph IV challenges on PFIZER drugs in the past three years. There is one tentative approval on PFIZER drugs.

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

Summary for Applicant: Pfizer

International Patents:1782
US Patents:58
Tradenames:120
Ingredients:106
NDAs:153
Drug Master File Entries: (click here to view)3
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
VISTARIL
hydroxyzine hydrochloride
INJECTABLE;INJECTION011111-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 2004ABRXYesNo► Subscribe► SubscribeY► Subscribe
Pfizer
TERRAMYCIN
oxytetracycline hydrochloride
CAPSULE;ORAL050286-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer Ireland
RELPAX
eletriptan hydrobromide
TABLET;ORAL021016-002Dec 26, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Pfizer
NAVANE
thiothixene
CAPSULE;ORAL016584-005Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
PFIZERPEN-AS
penicillin g procaine
INJECTABLE;INJECTION060286-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
SINEQUAN
doxepin hydrochloride
CAPSULE;ORAL016798-003Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Pfizer
PFIZERPEN G
penicillin g potassium
FOR SOLUTION;ORAL060587-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-002Jan 29, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL050710-002Oct 19, 1995ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Pfizer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
TROVAN
trovafloxacin mesylate
TABLET;ORAL020759-002Dec 18, 1997► Subscribe► Subscribe
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-001Jan 29, 1997► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
CAPSULE;ORAL020235-002Dec 30, 1993► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 2004► Subscribe► Subscribe
Pfizer Inc
FRAGMIN
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-003Mar 18, 1996► Subscribe► Subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-002Sep 6, 1989► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-002Jan 30, 2004► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006► Subscribe► Subscribe
Pfizer Pharms
ACCURETIC
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL020125-003Dec 28, 1999► Subscribe► Subscribe
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-001Jan 29, 1997► Subscribe► Subscribe
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Paragraph IV activity for PFIZER drugs

Drugname Dosage Strength Tradename Submissiondate
tofacitinib
Extended-release Tablets11 mg
XELJANZ XR
11/7/2016
ibuprofen and diphenhydramine citrate
Capsules200 mg/38 mg
ADVIL PM
2/16/2016
dofetilide
Capsules0.125 mg, 0.25 mg, and 0.5 mg
TIKOSYN
5/1/2014
fesoterodine fumarate
Extended-release Tablets4 mg and 8 mg
TOVIAZ
10/31/2012
nitroglycerin
Sublingual Tablets0.6 mg
NITROSTAT
12/29/2011
azithromycin
For Injection500 mg/vial
ZITHROMAX
6/17/2011
varenicline tartrate
Tablets0.5 mg and 1 mg
CHANTIX
5/10/2010
eletriptan hydrobromide
Tablets20 mg and 40 mg
RELPAX
3/29/2010
amlodipine besylate and atorvastatin calcium
Tablets2.5 mg/40 mg
CADUET
9/17/2009
amlodipine besylate and atorvastatin calcium
Tablets5 mg/80 mg
CADUET
4/7/2009
amlodipine besylate and atorvastatin calcium
Tablets5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg
CADUET
12/29/2006
sertraline hydrochloride
Tablets150 mg and 200 mg
ZOLOFT
11/9/2005
nitroglycerin
Sublingual Tablets0.3 mg, 0.4 mg and 0.6 mg
NITROSTAT
10/19/2005
zaleplon
Capsules5 mg and 10 mg
SONATA
6/21/2005
ziprasidone hydrochloride
Capsules20 mg, 40 mg, 60 mg and 80 mg
GEODON
2/7/2005
ibuprofen potassium and pseudoephedrine hydrochloride
Capsules200 mg/30 mg
ADVIL COLD AND SINUS
12/27/2004
sildenafil citrate
Tablets25 mg and 50 mg
VIAGRA
11/19/2004
sildenafil citrate
Tablets100 mg
VIAGRA
10/25/2004
irinotecan hydrochloride
Injection20 mg/mL, 2 mL and 5 mL vials
CAMPTOSAR
7/26/2004

Premature patent expirations for PFIZER

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book 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
6,737,045 Methods and compositions for the pulmonary delivery insulin► Subscribe
5,458,135 Method and device for delivering aerosolized medicaments► Subscribe
6,592,904 Dispersible macromolecule compositions and methods for their preparation and use► Subscribe
6,380,226 Salts of an anti-migraine indole derivatives► Subscribe
7,951,557Human lysosomal proteins from plant cell culture► Subscribe
5,775,320 Method and device for delivering aerosolized medicaments► Subscribe
9,364,541Pharmaceutical compositions comprising Fesoterodine► Subscribe
6,627,754 Pyrrolo[2,3-d]pyrimidine compounds► Subscribe
7,432,370Chiral salt resolution► Subscribe
6,951,938 Aryl fused azapolycyclic compounds► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Pfizer Drugs

Country Document Number Estimated Expiration
Australia702150► Subscribe
Hungary229867► Subscribe
Germany69835245► Subscribe
Colombia5640087► Subscribe
Australia662919► Subscribe
Japan3579060► Subscribe
Australia2009251081► Subscribe
Germany10299004► Subscribe
Austria284868► Subscribe
African Intellectual Property Organization (OAPI)11946► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Pfizer Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00375Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
C0013France► SubscribePRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
90005Netherlands► SubscribePRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
C0008Belgium► SubscribePRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
0355Netherlands► Subscribe300355, 20181113, EXPIRES: 20220425
2017 00030Denmark► SubscribePRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
2014 00050Denmark► SubscribePRODUCT 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
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Argus Health
Fish and Richardson
Novartis
AstraZeneca
Accenture
Merck
Cerilliant
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

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