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 twenty 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 nineteen supplementary protection certificates in eighteen countries.
Summary for APOTEX
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 239 |
| Ingredients: | 229 |
| NDAs: | 320 |
| 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 | MOMETASONE FUROATE | mometasone furoate | SPRAY, METERED;NASAL | 217438-001 | Apr 23, 2024 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apotex Inc | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075626-001 | Jul 24, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apotex Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 076274-001 | May 17, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 213159-001 | Mar 8, 2024 | DISCN | 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 | TABLET;ORAL | 020031-001 | Dec 29, 1992 | 5,872,132*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | 6,133,289*PED | ⤷ Sign Up |
| Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | 6,121,291*PED | ⤷ Sign Up |
| Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | 7,229,640*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 |
|---|---|---|---|---|
| 0364417 | C970039 | Netherlands | ⤷ Sign Up | PRODUCT NAME: [1R-[1 ALPHA (Z),2 BETA(R*),3 ALPHA,5ALPHA]]-7-[3,5-DIHYDROXY-2-(3-HYDROXY-5- FENYLPENTYL)CYCLOPENTYL]-5-HEPTEENZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN ESTER, IN HET BIJZONDER LATANOPROSTUM; NAT. REGISTRATION NO/DATE: RVG 21304 19970610; FIRST REGISTRATION: SE 12716 19960718 |
| 1973545 | SPC/GB13/077 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: UK EU/1/13/839/001 20130703; UK EU/1/13/839/002 20130703; UK EU/1/13/839/003 20130703; UK EU/1/13/839/004 20130703 |
| 1973545 | PA2013027,C1973545 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 03 EU/1/13/839/002, 2013 07 03 EU/1/13/839/003, 2013 07 03 EU/1/13/839/004 20130703 |
| 1392714 | CA 2017 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| >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.
