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Last Updated: February 12, 2025

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 LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 216944-001 Aug 25, 2023 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex DASATINIB dasatinib TABLET;ORAL 202103-001 Jun 10, 2016 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075412-001 Sep 8, 2000 DISCN No No ⤷  Try for Free ⤷  Try for Free
Apotex Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 078868-001 Feb 3, 2012 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076341-002 Oct 23, 2006 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex CLOBETASOL PROPIONATE clobetasol propionate SPRAY;TOPICAL 210446-001 Apr 17, 2018 DISCN No No ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Apotex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 5,789,449*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 5,900,423*PED ⤷  Try for Free
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000 6,063,927*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 6,080,759*PED ⤷  Try for Free
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 5,789,449*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 6,080,759*PED ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0124495 SPC/GB01/006 United Kingdom ⤷  Try for Free PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0450097 C300408 Netherlands ⤷  Try for Free PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
1534313 92923 Luxembourg ⤷  Try for Free PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
0788360 04C0014 France ⤷  Try for Free PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
2924034 C201930027 Spain ⤷  Try for Free PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122
1261586 15/2012 Austria ⤷  Try for Free PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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