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 eleven 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 eight hundred and three supplementary protection certificates in eighteen countries.
Summary for APOTEX
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 231 |
| Ingredients: | 223 |
| NDAs: | 311 |
| 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 | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 076048-002 | Oct 22, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204159-005 | Jul 5, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apotex | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 074943-002 | Dec 19, 2000 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | 6,133,289*PED | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | 5,789,449*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | 6,121,291*PED | ⤷ Sign Up |
| >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 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APOTEX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0467488 | SPC/GB00/019 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607 |
| 0253310 | SPC/GB95/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215 |
| 0817775 | 5/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: ERLOTINIB UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE ERLOTINIBHYDROCHLORID; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 - EU/1/05/311/003 20050919; FIRST REGISTRATION: CH 57266 01 - 57266 03 20050321 |
| >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.
