APOTEX Company Profile
✉ Email this page to a colleague
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 sixteen 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 | PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713-001 | Oct 19, 2023 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex Inc | VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 203026-004 | Mar 21, 2013 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Apotex Inc | RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 202477-001 | Jul 1, 2013 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Apotex | PREGABALIN | pregabalin | CAPSULE;ORAL | 211685-004 | Jul 7, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 205876-001 | Sep 21, 2016 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Apotex | TEMOZOLOMIDE | temozolomide | CAPSULE;ORAL | 204159-003 | Jul 5, 2018 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| >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 CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | 5,789,449*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | 6,133,289*PED | ⤷ Subscribe |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | 6,063,927*PED | ⤷ Subscribe |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 6,063,927*PED | ⤷ Subscribe |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 6,133,289*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | 6,063,927*PED | ⤷ Subscribe |
| >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 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APOTEX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3808743 | CA 2022 00035 | Denmark | ⤷ Subscribe | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
| 1261586 | 12C0028 | France | ⤷ Subscribe | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
| 1214076 | 49/2008 | Austria | ⤷ Subscribe | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 2487166 | PA2016038 | Lithuania | ⤷ Subscribe | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| 0236940 | 97C0053 | Belgium | ⤷ Subscribe | PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072 |
| 0480717 | 19/1999 | Austria | ⤷ Subscribe | PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825 |
| >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.
