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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
US Department of Justice
Chubb
UBS
Accenture
Healthtrust
Teva
Farmers Insurance
Merck

Generated: August 17, 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-nine 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 Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-002Aug 19, 2016RXNoNo► Subscribe► SubscribeY ► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-004Jan 30, 2004ABRXYesNo► Subscribe► Subscribe ► Subscribe
Pfizer
ZITHROMAX
azithromycin
CAPSULE;ORAL050670-001Nov 1, 1991DISCNYesNo► Subscribe► Subscribe► Subscribe
Pfizer
GLUCOTROL
glipizide
TABLET;ORAL017783-001May 8, 1984ABRXYesNo► Subscribe► Subscribe► Subscribe
Pfizer
CHILDREN'S ADVIL
ibuprofen
SUSPENSION;ORAL020589-001Jun 27, 1996OTCNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Pfizer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
GEODON
ziprasidone hydrochloride
CAPSULE;ORAL020825-001Feb 5, 2001► Subscribe► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 2000► Subscribe► Subscribe
Pfizer Pharms
NEURONTIN
gabapentin
TABLET;ORAL020882-001Oct 9, 1998► Subscribe► Subscribe
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 1996► Subscribe► Subscribe
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-007Jan 30, 2004► 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
6,423,344 Dispersible macromolecule compositions and methods for their preparation and use► Subscribe
6,407,236 Adenosine A3 receptor modulators► Subscribe
8,778,390Orally effective methylphenidate extended release powder and aqueous suspension product► Subscribe
5,780,014 Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin► Subscribe
9,675,704Modified 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
Ireland882107► Subscribe
Norway20005669► Subscribe
Peru16397► Subscribe
Brazil0214761► Subscribe
Eurasian Patent Organization200400860► 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
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2017000014Germany► SubscribePRODUCT NAME: PALBOCICLIB, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDES ODER EINES PRODRUGS HIERVON; REGISTRATION NO/DATE: EU/1/16/1147 20161109
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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:

Colorcon
Harvard Business School
Argus Health
Medtronic
US Department of Justice
Cipla
Teva
QuintilesIMS
McKesson
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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