Apotex Company Profile
What is the competitive landscape for APOTEX
APOTEX has three hundred and sixty-five approved drugs.
There are sixteen US patents protecting APOTEX drugs. There are twenty-two tentative approvals on APOTEX drugs.
Summary for Apotex
| US Patents: | 16 |
| Tradenames: | 277 |
| Ingredients: | 265 |
| NDAs: | 365 |
| 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 | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 209085-001 | May 25, 2022 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 202620-001 | Jun 23, 2014 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-003 | Jan 25, 2019 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | APIXABAN | apixaban | TABLET;ORAL | 210091-002 | Feb 16, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start 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 | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-002 | Sep 11, 2009 | 7,008,923 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 7,544,364 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 8,101,575 | ⤷ Start Trial |
| Apotex | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-001 | Jun 11, 2009 | 6,727,286 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 6,858,584 | ⤷ Start 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 | Transdermal System | 3.1 mg/24 hrs | ➤ Subscribe | 2015-10-09 |
| ➤ Subscribe | Extended-release Tablets | 25 mg | ➤ Subscribe | 2005-09-09 |
| ➤ Subscribe | Oral Suspension | 10 mg/5 mL | ➤ Subscribe | 2005-02-10 |
| ➤ Subscribe | Injection | 200 mg/mL, 30 mL vials | ➤ Subscribe | 2012-04-04 |
| ➤ Subscribe | Extended-release Tablets | 37.5 mg | ➤ Subscribe | 2009-05-19 |
International Patents for Apotex Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 102413687 | ⤷ Start Trial |
| New Zealand | 566100 | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2010105129 | ⤷ Start Trial |
| Japan | 5837877 | ⤷ Start Trial |
| Canada | 2754922 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apotex Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1412357 | C300287 | Netherlands | ⤷ Start Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 |
| 0162036 | 2000C/032 | Belgium | ⤷ Start Trial | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| 0296749 | SPC/GB96/004 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: ANASTROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT; REGISTRATION NO/DATE: UK 12619/0106 19950811 |
| 3141251 | C202130017 | Spain | ⤷ Start Trial | PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016 |
| 2269604 | CA 2016 00060 | Denmark | ⤷ Start Trial | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805 |
| >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.
