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Last Updated: March 18, 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 ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc MONTELUKAST SODIUM montelukast sodium TABLET, CHEWABLE;ORAL 201508-001 Aug 3, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex ALKERAN melphalan TABLET;ORAL 014691-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Apotex FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252-002 Jul 26, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc ZOLMITRIPTAN zolmitriptan TABLET;ORAL 202078-001 May 14, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Apotex FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 208150-001 Feb 29, 2016 OTC 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 020031-005 Dec 29, 1992 6,063,927*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 5,900,423*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 6,080,759*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 5,789,449*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 5,872,132*PED ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 5,872,132*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 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
3808743 2290034-4 Sweden ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
0459136 98C0016 Belgium ⤷  Try a Trial PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429
2101777 122016000039 Germany ⤷  Try a Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0564409 2002/005 Ireland ⤷  Try a Trial PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0124495 SPC/GB01/006 United Kingdom ⤷  Try a Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1381356 SPC/GB14/011 United Kingdom ⤷  Try a Trial PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.