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 eight 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 seven hundred and seven supplementary protection certificates in seventeen countries.
Summary for Apotex
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 230 |
| Ingredients: | 222 |
| NDAs: | 308 |
| 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 Inc | LETROZOLE | letrozole | TABLET;ORAL | 091303-001 | Apr 19, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Apotex | IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 079179-001 | Aug 5, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex Inc | ALPRAZOLAM | alprazolam | TABLET;ORAL | 077741-002 | Jan 19, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | VALACYCLOVIR HYDROCHLORIDE | valacyclovir hydrochloride | TABLET;ORAL | 090500-002 | Apr 4, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 205199-007 | Nov 18, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | ERLOTINIB HYDROCHLORIDE | erlotinib hydrochloride | TABLET;ORAL | 208396-001 | Nov 5, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 075580-003 | Oct 18, 2000 | 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 | 020031-002 | Dec 29, 1992 | 6,121,291*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | 6,080,759*PED | ⤷ Try a Trial |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | 6,080,759*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | 6,121,291*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 6,113,944*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 5,872,132*PED | ⤷ Try a Trial |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 5,900,423*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 |
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 |
|---|---|---|---|---|
| 1343782 | 2010C/030 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PAZOPANIB, OPTIONNELLEMENT SOUS LA FORME DE SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU DE SON SOLVATE; AUTHORISATION NUMBER AND DATE: EU/1/110/628/01 20100616 |
| 1345920 | 92381 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT) |
| 0721777 | SPC/GB04/033 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETINE, OPTIONALLY IN THE FORM OF A SALT, SUCH AS THE HYDROCHLORIDE; REGISTERED: UK PL 00006/0374 20040527; UK PL 00006/0375 20040527; UK PL 00006/0376 20040527; UK PL 00006/0377 20040527; UK PL 00006/0378 20040527; UK PL 00006/0379 20040527 |
| 1169038 | 132013902119320 | Italy | ⤷ Try a Trial | PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120 |
| 0656775 | CR 2000 00018 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| 1003503 | C01003503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 |
| 0236684 | C300140 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
