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Impax Company Profile

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IMPAX has one hundred and fifty-one approved drugs.

There are thirteen US patents protecting IMPAX drugs. There are four tentative approvals on IMPAX drugs.

There are eighty-seven patent family members on IMPAX drugs in nineteen countries and one hundred and fourteen supplementary protection certificates in sixteen countries.

International Patents:	87
US Patents:	13
Tradenames:	120
Ingredients:	117
NDAs:	151
Patent Litigation for Impax:	See patent lawsuits for Impax
PTAB Cases with Impax as petitioner:	See PTAB cases with Impax 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
Impax Labs Inc	URSODIOL	ursodiol	TABLET;ORAL	200826-001	Dec 23, 2011	AB	RX	No	No		Start Trial				Start Trial
Impax Labs	TETRACYCLINE HYDROCHLORIDE	tetracycline hydrochloride	CAPSULE;ORAL	060469-002	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Impax Labs	CHLOROQUINE PHOSPHATE	chloroquine phosphate	TABLET;ORAL	080880-001	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Impax Labs	ACARBOSE	acarbose	TABLET;ORAL	078441-003	May 14, 2009	AB	RX	No	No		Start Trial				Start 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
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	5,665,071	Start Trial
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	5,665,071	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Capsules	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg	➤ Subscribe	2015-06-24
➤ Subscribe	Extended-release Capsules	61.25 mg/245 mg	➤ Subscribe	2015-06-10
➤ Subscribe	Delayed-release Tablets	20 mg	➤ Subscribe	2015-06-03

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	179 5017-2014	Slovakia	Start Trial	PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1175904	2007C/048	Belgium	Start Trial	PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1746976	CA 2017 00030	Denmark	Start Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
0480717	98C0025	Belgium	Start Trial	PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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