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Last Updated: March 28, 2024

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 ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079145-001 Jul 19, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204159-003 Jul 5, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 078794-004 Aug 21, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071196-001 Mar 25, 1987 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Apotex Corp VERAPAMIL HYDROCHLORIDE verapamil hydrochloride TABLET, EXTENDED RELEASE;ORAL 200878-002 Apr 20, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 091431-005 Dec 30, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Apotex ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208453-001 Oct 31, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
>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 TABLET;ORAL 020031-003 Dec 29, 1992 6,133,289*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 6,133,289*PED ⤷  Try a Trial
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 7,229,640*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 6,121,291*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-005 Dec 29, 1992 5,872,132*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 6,063,927*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 6,080,759*PED ⤷  Try a Trial
>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 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 C990006 Netherlands ⤷  Try a Trial PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
0253310 C950009 Netherlands ⤷  Try a Trial PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
1411900 SPC/GB11/015 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
3461484 132021000000068 Italy ⤷  Try a Trial PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3225249 CA 2019 00023 Denmark ⤷  Try a Trial PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504
0265685 C980030 Netherlands ⤷  Try a Trial PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
1920764 PA2012017 Lithuania ⤷  Try a Trial PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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