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 nineteen 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 twenty supplementary protection certificates in eighteen countries.
Summary for APOTEX
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 238 |
| Ingredients: | 228 |
| NDAs: | 319 |
| 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 | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 090548-001 | May 29, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | MOMETASONE FUROATE | mometasone furoate | SPRAY, METERED;NASAL | 091161-001 | Mar 22, 2016 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 206776-003 | May 23, 2017 | DISCN | 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 | TABLET;ORAL | 020031-005 | Dec 29, 1992 | 6,133,289*PED | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 5,872,132*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | 4,721,723*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 |
|---|---|---|---|---|
| 1189916 | 122011000010 | Germany | ⤷ Sign Up | PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
| 1973545 | C01973545/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: SWISSMEDIC 63097 12.02.2014 |
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
| >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.
