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 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 | DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 075580-002 | Oct 18, 2000 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex Inc | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; triamterene | TABLET;ORAL | 071251-002 | May 5, 1998 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076140-003 | Sep 26, 2002 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex | CELECOXIB | celecoxib | CAPSULE;ORAL | 204197-003 | Jun 2, 2015 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 209085-001 | May 25, 2022 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex | DOXAZOSIN MESYLATE | doxazosin mesylate | TABLET;ORAL | 075580-001 | Oct 18, 2000 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Apotex Inc | MIRTAZAPINE | mirtazapine | TABLET;ORAL | 077666-001 | Aug 22, 2007 | AB | RX | 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 | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | 6,133,289*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | 6,172,233*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | 6,113,944*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 | 6,080,759*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 6,063,927*PED | ⤷ Subscribe |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-002 | Oct 9, 1998 | 5,872,132*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 | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | Extended-release Tablets | 25 mg | ➤ Subscribe | 2005-09-09 |
| ➤ Subscribe | Oral Suspension | 10 mg/5 mL | ➤ Subscribe | 2005-02-10 |
| ➤ Subscribe | Extended-release Tablets | 37.5 mg | ➤ Subscribe | 2009-05-19 |
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 |
|---|---|---|---|---|
| 0966454 | SZ 19/2008 | Austria | ⤷ Subscribe | PRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT |
| 1301519 | 11/2016 | Austria | ⤷ Subscribe | PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123 |
| 2498758 | CR 2020 00017 | Denmark | ⤷ Subscribe | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
| 1189916 | C01189916/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017 |
| 0454511 | 98C0028 | Belgium | ⤷ Subscribe | PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815 |
| 1920764 | PA2012017,C1920764 | Lithuania | ⤷ Subscribe | PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127 |
| 3808743 | LUC00275 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128 |
| >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.
