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 eleven 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 three supplementary protection certificates in eighteen countries.
Summary for Apotex
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 231 |
| Ingredients: | 223 |
| NDAs: | 311 |
| 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 | 090548-004 | May 29, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075191-001 | Jun 9, 1999 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 211022-005 | Mar 7, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex Inc | CROMOLYN SODIUM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 075615-001 | Jan 26, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apotex Inc | KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077354-001 | May 9, 2006 | OTC | 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 | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | 6,172,233*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 6,080,759*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | 6,172,233*PED | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-002 | Feb 16, 1999 | 5,900,423*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | 6,172,233*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 |
|---|---|---|---|---|
| 2236132 | 122015000006 | Germany | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718 |
| 1419152 | C 2012 016 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
| 2924034 | 132019000000062 | Italy | ⤷ Sign Up | PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON LAMIVUDINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON TENOFOVIR O UN SUO ESTERE, IN PARTICOLARE UN ESTERE DI DISOPROXIL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE UN SALE FUMARATO(DELSTRIGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1333/001-002, 20181127 |
| 0138504 | 2004C/004 | Belgium | ⤷ Sign Up | PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311 |
| 3632448 | 22C1031 | France | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
| >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.
