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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Chubb
Queensland Health
QuintilesIMS
Covington
Baxter
McKinsey
US Army

Generated: January 16, 2019

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Apotex Company Profile

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Summary for Apotex

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 HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 040774-002 Oct 3, 2007 DISCN No No ➤ Sign Up ➤ Sign Up
Apotex Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090151-004 Apr 30, 2012 AB RX No No ➤ Sign Up ➤ Sign Up
Apotex Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 200266-002 Sep 10, 2013 AB RX No No ➤ Sign Up ➤ Sign Up
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 paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 6,172,233*PED ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 6,121,291*PED ➤ Sign Up
Apotex Technologies PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 5,872,132*PED ➤ Sign Up
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 Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Extended-release Tablets 25 mg ➤ Subscribe 2005-09-09
➤ Subscribe Oral Suspension 10 mg/5 mL ➤ Subscribe 2005-02-10
➤ Subscribe Extended-release Tablets 37.5 mg ➤ Subscribe 2009-05-19

Supplementary Protection Certificates for Apotex Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/031 United Kingdom ➤ Sign Up PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
2016 00066 Denmark ➤ Sign Up PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
2017 00004 Denmark ➤ Sign Up PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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.

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
McKesson
Mallinckrodt
UBS
Fish and Richardson
Boehringer Ingelheim
Julphar
Federal Trade Commission
Argus Health

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