Apotex Company Profile
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What is the competitive landscape for APOTEX, and what generic alternatives to APOTEX drugs are available?
APOTEX has three hundred and six approved drugs.
There is one US patent protecting APOTEX drugs. There are fifteen tentative approvals on APOTEX drugs.
There is one patent family member on APOTEX drugs in one country and six hundred and ninety-four supplementary protection certificates in seventeen countries.
Summary for Apotex
International Patents: | 1 |
US Patents: | 1 |
Tradenames: | 228 |
Ingredients: | 220 |
NDAs: | 306 |
Patent Litigation for Apotex: | See patent lawsuits for Apotex |
PTAB Cases with Apotex as petitioner: | See PTAB cases with Apotex as petitioner |
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 |
International Patents for Apotex Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2017002030 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
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
Here is a list of applicants with similar names.