Apotex Company Profile

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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 seven supplementary protection certificates in seventeen countries.

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

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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	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	078794-004	Aug 21, 2014	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	077120-002	Jun 2, 2008	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075580-002	Oct 18, 2000	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	075441-001	Mar 28, 2001		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075984-001	Apr 23, 2002	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	GABAPENTIN	gabapentin	TABLET;ORAL	077894-001	Oct 10, 2006	AB1	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071196-001	Mar 25, 1987	AB	RX	No	Yes		⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	6,121,291*PED	⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992	6,080,759*PED	⤷ Try a Trial
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999	6,080,759*PED	⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,121,291*PED	⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-001	Dec 29, 1992	6,113,944*PED	⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-001	Dec 29, 1992	5,872,132*PED	⤷ Try a Trial
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	5,900,423*PED	⤷ Try a Trial
>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	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193926	C980031	Netherlands	⤷ Try a Trial	PRODUCT NAME: RIVASTIGMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RIVASTIGMINE WATERSTOFTAR- TRAAT; REGISTRATION NO/DATE: EU/1/98/066/001 - EU/1/98/066/012 19980512
1485094	CA 2012 00054	Denmark	⤷ Try a Trial	PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
0966454	SZ 19/2008	Austria	⤷ Try a Trial	PRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT
1915993	300625	Netherlands	⤷ Try a Trial	PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
1381356	14C0010	France	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2236132	92636	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2924034	1990024-0	Sweden	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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