APOTEX Company Profile
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What is the competitive landscape for APOTEX, and when can generic versions of APOTEX drugs launch?
APOTEX has three hundred and eight 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 seven hundred and six supplementary protection certificates in seventeen countries.
Summary for APOTEX
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 230 |
| Ingredients: | 222 |
| NDAs: | 308 |
| 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 | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | SOLUTION;INTRAVENOUS | 217110-001 | Aug 18, 2023 | RX | Yes | Yes | 10,537,520 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Apotex | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 208740-001 | Jun 16, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Apotex Inc | ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 090548-004 | May 29, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | TABLET;ORAL | 076140-001 | Sep 26, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apotex | LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 211022-005 | Mar 7, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a 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 | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 5,872,132*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-002 | Dec 29, 1992 | 6,172,233*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | 5,872,132*PED | ⤷ Try a Trial |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | 4,721,723*PED | ⤷ Try a Trial |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | 5,900,423*PED | ⤷ Try a 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 | 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 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APOTEX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | C300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
| 1519731 | 132013902182575 | Italy | ⤷ Try a Trial | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
| 0720599 | 122014000088 | Germany | ⤷ Try a Trial | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912 |
| 2435025 | LUC00124 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
| >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.
