APOTEX Company Profile

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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.

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	CEFTAROLINE FOSAMIL	ceftaroline fosamil	POWDER;INTRAVENOUS	208075-001	Sep 21, 2021		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Apotex	ENZALUTAMIDE	enzalutamide	CAPSULE;ORAL	209645-001	Apr 22, 2022		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Apotex	TICLOPIDINE HYDROCHLORIDE	ticlopidine hydrochloride	TABLET;ORAL	075089-001	Jul 1, 1999		RX	No	Yes		⤷ Sign Up				⤷ Sign Up
Apotex Inc	CALCITONIN-SALMON	calcitonin salmon	SPRAY, METERED;NASAL	076396-001	Nov 17, 2008		RX	No	Yes		⤷ 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

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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	6,080,759*PED	⤷ Sign Up
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	4,721,723*PED	⤷ Sign Up
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998	5,872,132*PED	⤷ Sign Up
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992	6,113,944*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Oral Suspension	10 mg/5 mL	➤ Subscribe	2005-02-10

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017002030	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300375	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
2443246	122021000056	Germany	⤷ Sign Up	PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
1506211	C 2014 029	Romania	⤷ Sign Up	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
0053902	96C0036	Belgium	⤷ Sign Up	PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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