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Serving 500+ biopharmaceutical companies globally:

Cipla
Baxter
Deloitte
Julphar
Fish and Richardson
Colorcon
Mallinckrodt
Queensland Health
Johnson and Johnson
Accenture

Generated: August 17, 2017

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Apotex Company Profile

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What is the competitive landscape for APOTEX, and what generic alternatives to APOTEX drugs are available?

APOTEX has two hundred and ninety-three approved drugs.

There are five US patents protecting APOTEX drugs on APOTEX drugs in the past three years. There are seventeen tentative approvals on APOTEX drugs.

There are two hundred and fourteen patent family members on APOTEX drugs in fifty-one countries.

Summary for Applicant: Apotex

Patents:5
Tradenames:219
Ingredients:207
NDAs:293
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride
TABLET;ORAL077746-002Sep 12, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
CELECOXIB
celecoxib
CAPSULE;ORAL204197-003Jun 2, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
CANDESARTAN CILEXETIL
candesartan cilexetil
TABLET;ORAL202079-002Jan 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex
CIMETIDINE
cimetidine
TABLET;ORAL074890-002Dec 18, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET;ORAL065317-003Oct 20, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Apotex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
SUSPENSION;ORAL020710-001Jun 25, 1997► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031-005Dec 29, 1992► Subscribe► Subscribe
Apotex Technologies
PAXIL
paroxetine hydrochloride
CAPSULE;ORAL020885-001Oct 9, 1998► Subscribe► Subscribe
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Paragraph IV activity for APOTEX drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazole
Delayed-release Tablets20 mg
OMEPRAZOLE
6/3/2015
paroxetine hydrochloride
Extended-release Tablets37.5 mg
PAXIL CR
5/19/2009
paroxetine hydrochloride
Extended-release Tablets25 mg
PAXIL CR
9/9/2005
paroxetine hydrochloride
Oral Suspension10 mg/5 mL
PAXIL
2/10/2005

International Patent Family for Apotex Drugs

Country Document Number Estimated Expiration
Denmark0839039► Subscribe
Morocco23942► Subscribe
Bulgaria102259► Subscribe
Eurasian Patent Organization003508► Subscribe
Belgium1012420► 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 Apotex Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0014France► SubscribePRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
C0040France► SubscribePRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB05/003United Kingdom► SubscribePRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
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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:

McKinsey
US Army
Novartis
Accenture
Julphar
Dow
Deloitte
Argus Health
Farmers Insurance
Teva

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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