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 Corp	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	090790-002	Oct 6, 2010		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Apotex Inc	MIRTAZAPINE	mirtazapine	TABLET;ORAL	077666-001	Aug 22, 2007	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Apotex	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	077982-004	Aug 4, 2008	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Apotex Inc	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	201508-001	Aug 3, 2012		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

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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	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

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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
0265685	SPC/GB98/047	United Kingdom	⤷ Sign Up	PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0382526	19675032	Germany	⤷ Sign Up	PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
0564409	SPC/GB02/016	United Kingdom	⤷ Sign Up	PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
1632232	PA2016043	Lithuania	⤷ Sign Up	PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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