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 Corp	CABERGOLINE	cabergoline	TABLET;ORAL	201503-001	Mar 8, 2013		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	GEFITINIB	gefitinib	TABLET;ORAL	209532-001	Sep 23, 2022	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	211022-004	Aug 30, 2022	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Apotex	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079145-003	Jul 19, 2016		DISCN	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

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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
>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
0771217	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
3461484	122021000036	Germany	⤷ Try a Trial	PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
1427415	PA2011012	Lithuania	⤷ Try a Trial	PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
0281459	C990002	Netherlands	⤷ Try a Trial	PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.