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 twenty approved drugs.
There is one US patent protecting APOTEX drugs. There are sixteen tentative approvals on APOTEX drugs.
There is one patent family member on APOTEX drugs in one country and eight hundred and thirty-nine supplementary protection certificates in eighteen countries.
Summary for Apotex
International Patents: | 1 |
US Patents: | 1 |
Tradenames: | 239 |
Ingredients: | 229 |
NDAs: | 320 |
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 | 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 |
International Patents for Apotex Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2017002030 | ⤷ Try for Free |
>Country | >Patent Number | >Estimated Expiration |
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
Here is a list of applicants with similar names.