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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Fish and Richardson
Accenture
Queensland Health
Covington
US Department of Justice
Baxter
Julphar
Healthtrust

Generated: July 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-five 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 seventy-seven patent family members on PFIZER drugs in seventy-nine countries.

Summary for Applicant: Pfizer

Patents:58
Tradenames:122
Ingredients:107
NDAs:155
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
TETRACYN
tetracycline hydrochloride
INJECTABLE;INJECTION060096-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Pfizer
EXUBERA
insulin recombinant human
POWDER;INHALATION021868-001Jan 27, 2006DISCNNoNo6,546,929► Subscribe ► Subscribe
Pfizer Inc
CAMPTOSAR
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996APRXYesYes6,794,370*PED► SubscribeY► Subscribe
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-001Aug 19, 2016RXNoNo8,685,443► Subscribe ► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-010Jul 29, 2004ABRXYesNo5,969,156*PED► SubscribeY► Subscribe
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Expired Patents for Pfizer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-008Jan 30, 20046,126,971*PED► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-008Jan 30, 20044,879,303*PED► Subscribe
Pfizer Pharms
REZULIN
troglitazone
TABLET;ORAL020720-003Aug 4, 19975,478,852► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-001Jan 30, 2004RE40667*PED► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 19965,969,156*PED► 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
6,592,904 Dispersible macromolecule compositions and methods for their preparation and use► Subscribe
6,372,258 Methods of spray-drying a drug and a hydrophobic amino acid► Subscribe
5,545,413 Dosage form for administering oral hypoglycemic glipizide► Subscribe
7,470,698Adenosine A3 receptor modulators► Subscribe
8,883,217Modified release formulations containing drug-ion exchange resin complexes► 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
European Patent Office0940154► Subscribe
Japan2904588► Subscribe
Eurasian Patent Organization200100285► Subscribe
European Patent Office1259489► Subscribe
Argentina045528► 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
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
/1997Austria► SubscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
C0013France► SubscribePRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
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
C0039France► SubscribePRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
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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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Serving 500+ biopharmaceutical companies globally:

McKesson
Merck
Julphar
Cipla
Express Scripts
Argus Health
Chinese Patent Office
Moodys
McKinsey
Colorcon

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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