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Serving leading biopharmaceutical companies globally:

Argus Health
McKinsey
Covington
Johnson and Johnson
Federal Trade Commission
Teva
Colorcon
US Army
Medtronic
Moodys

Generated: December 17, 2017

DrugPatentWatch Database Preview

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-four 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 thirteen patent family members on APOTEX drugs in fifty-one countries and three hundred and fourteen supplementary protection certificates in thirteen countries.

Summary for Apotex

International Patents:213
US Patents:5
Tradenames:220
Ingredients:208
NDAs:294
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex IncARIPIPRAZOLEaripiprazoleTABLET;ORAL078583-005Jul 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncDILTZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL076395-005Feb 1, 2006AB4RXNoNo► Subscribe► Subscribe► Subscribe
ApotexPERINDOPRIL ERBUMINEperindopril erbumineTABLET;ORAL090463-001Aug 30, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncLEVOFLOXACINlevofloxacinSOLUTION/DROPS;OPHTHALMIC078282-001Dec 20, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex IncATOMOXETINE HYDROCHLORIDEatomoxetine hydrochlorideCAPSULE;ORAL078983-002May 30, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
ApotexCIMETIDINEcimetidineTABLET;ORAL074890-002Dec 18, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
ApotexCIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochlorideTABLET;ORAL076896-002Nov 4, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncLEVETIRACETAMlevetiracetamTABLET, EXTENDED RELEASE;ORAL091261-001Sep 12, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncBENZONATATEbenzonatateCAPSULE;ORAL091310-002Jan 16, 2015AARXNoNo► Subscribe► Subscribe► Subscribe
ApotexKETOCONAZOLEketoconazoleTABLET;ORAL075912-001Jan 10, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Apotex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-002Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-003Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideCAPSULE;ORAL020885-001Oct 9, 1998► Subscribe► Subscribe
Apotex TechnologiesPAXILparoxetine hydrochlorideTABLET;ORAL020031-004Dec 29, 1992► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000► Subscribe► Subscribe
Apotex TechnologiesPAXIL CRparoxetine hydrochlorideTABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999► Subscribe► Subscribe
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Paragraph IV activity for APOTEX drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazoleDelayed-release Tablets20 mgOMEPRAZOLE6/3/2015
paroxetine hydrochlorideExtended-release Tablets37.5 mgPAXIL CR5/19/2009
paroxetine hydrochlorideExtended-release Tablets25 mgPAXIL CR9/9/2005
paroxetine hydrochlorideOral Suspension10 mg/5 mLPAXIL2/10/2005

International Patent Family for Apotex Drugs

Country Document Number Estimated Expiration
United Kingdom9914712► Subscribe
Poland324553► Subscribe
Turkey200100054► Subscribe
Denmark0970955► Subscribe
Denmark199901730► Subscribe
South Africa9902899► Subscribe
France2795327► Subscribe
United Kingdom2367003► Subscribe
United Kingdom0026487► Subscribe
Finland990922► 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
1003503/01Switzerland► SubscribePRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
C/GB99/020United Kingdom► SubscribePRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
00688Netherlands► SubscribePRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
C/GB99/001United Kingdom► SubscribePRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715
00C/015Belgium► SubscribePRODUCT NAME: QUETIAPINE FUMARAT (EQUIV. MET 25MG QUETIAPINE BASE); REGISTRATION NO/DATE: 624 S 309 F 3 20000207; FIRST REGISTRATION: GB PL 12619/0113 19970731
00567Netherlands► SubscribePRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C/GB01/012United Kingdom► SubscribePRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
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
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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 leading biopharmaceutical companies globally:

Deloitte
Cipla
Johnson and Johnson
McKesson
UBS
Dow
Moodys
Queensland Health
Baxter
Novartis

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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