Apotex Company Profile
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What is the competitive landscape for APOTEX
APOTEX has three hundred and sixty-four approved drugs.
There are sixteen US patents protecting APOTEX drugs. There are nineteen tentative approvals on APOTEX drugs.
Summary for Apotex
| US Patents: | 16 |
| Tradenames: | 276 |
| Ingredients: | 264 |
| NDAs: | 364 |
| 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 | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078449-003 | Nov 12, 2008 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex Inc | CLEMASTINE FUMARATE | clemastine fumarate | SYRUP;ORAL | 075703-001 | Nov 27, 2000 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | TOLVAPTAN | tolvaptan | TABLET;ORAL | 218381-005 | Nov 10, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apotex | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214969-001 | Sep 2, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apotex Inc | DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 022312-002 | Jan 11, 2012 | 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 | 7,208,471 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 7,008,923 | ⤷ Start Trial |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | 6,062,927 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 8,158,580 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 7,544,364 | ⤷ 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 |
|---|---|---|
| Peru | 20150083 | ⤷ Start Trial |
| China | 103038356 | ⤷ Start Trial |
| Taiwan | I342312 | ⤷ Start Trial |
| European Patent Office | 2458988 | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2010105129 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apotex Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1409467 | 2015/027 | Ireland | ⤷ Start Trial | PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119 |
| 1631293 | 300683 | Netherlands | ⤷ Start Trial | PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225 |
| 1663240 | PA2015037 | Lithuania | ⤷ Start Trial | PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128 |
| 1870100 | 132012902065811 | Italy | ⤷ Start Trial | PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/001-2-3-4-5-6-7-8, 20080318 |
| 1973545 | C 2013 039 | Romania | ⤷ Start Trial | PRODUCT NAME: PONATINIB SI SARURILE SALE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF NATIONAL AUTHORISATION: 20130701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF FIRST AUTHORISATION IN EEA: 20130701 |
| >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.
