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Last Updated: January 28, 2020

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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 BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 077128-003 Mar 8, 2006 AB RX No No   Start Trial   Start Trial
Apotex Inc CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 202079-004 Jan 10, 2014 DISCN No No   Start Trial   Start Trial
Apotex Inc LOVASTATIN lovastatin TABLET;ORAL 077748-002 Feb 28, 2007 AB RX No No   Start Trial   Start Trial
Apotex AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 205199-001 Nov 18, 2019 AB RX No No   Start Trial   Start Trial
Apotex Inc ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 078990-004 Sep 28, 2018 AP RX No No   Start Trial   Start Trial
Apotex BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 078794-004 Aug 21, 2014 AB RX No No   Start Trial   Start Trial
Apotex Inc TOBRAMYCIN tobramycin SOLUTION/DROPS;OPHTHALMIC 065087-001 Feb 25, 2002 DISCN No No   Start Trial   Start 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 Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 5,900,423*PED   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 6,063,927*PED   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 5,900,423*PED   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 6,133,289*PED   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 5,900,423*PED   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 6,133,289*PED   Start Trial
Apotex Technologies PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 4,721,723*PED   Start 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 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
1441735 SPC/GB08/020 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
2506844 1890025-8 Sweden   Start Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1412357 CA 2008 00035 Denmark   Start Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
0663828 C300085 Netherlands   Start Trial PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
1305329 SPC/GB08/026 United Kingdom   Start Trial PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
1534313 CA 2015 00072 Denmark   Start Trial PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
0812190 31/2005 Austria   Start Trial PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Colorcon

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