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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
US Army
QuintilesIMS
US Department of Justice
Accenture
Fish and Richardson
Deloitte
Harvard Business School

Generated: September 20, 2018

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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 three hundred and six approved drugs.

There are two US patents protecting APOTEX drugs. There are seventeen tentative approvals on APOTEX drugs.

Drugs and US Patents for Apotex

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022312-001 Jan 11, 2012 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 200172-001 May 31, 2012 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 078623-002 Apr 5, 2010 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 202244-002 Dec 31, 2012 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077781-001 Sep 27, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Apotex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000 6,133,289*PED ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 5,789,449*PED ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 4,721,723*PED ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 5,900,423*PED ➤ Try a Free Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 4,721,723*PED ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for APOTEX drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Suspension 10 mg/5 mL ➤ Subscribe 2005-02-10
➤ Subscribe Extended-release Tablets 37.5 mg ➤ Subscribe 2009-05-19
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Extended-release Tablets 25 mg ➤ Subscribe 2005-09-09

Supplementary Protection Certificates for Apotex Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90005 Netherlands ➤ Try a Free Trial PRODUCT 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
91028-4 Sweden ➤ Try a Free Trial PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT
2014 00037 Denmark ➤ Try a Free Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
00110 Netherlands ➤ Try a Free Trial PRODUCT NAME: GATIFLOXACINUM, DESGEWENST IN DE VORM VAN EEN HYDRAAT, ZUURADDITIEZOUT OF ALKALISCH ZOUT, IN HET BIJZONDER GATIFLOXACINUM SESQUIHYDRICUM; REGISTRATION NO/DATE: DE 48870.00.00, 48870.01.00, 48872.00.00, 48872.01.00, 48874.00.00, 48874.01.00, 48876.00.00, 48876.01.00 20011022
00528 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Boehringer Ingelheim
UBS
Argus Health
Federal Trade Commission
Julphar
Daiichi Sankyo
McKesson

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