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Impax Company Profile

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What is the competitive landscape for IMPAX, and when can generic versions of IMPAX drugs launch?

IMPAX has one hundred and fifty-two approved drugs.

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

There are eighty-one patent family members on IMPAX drugs in eighteen countries and one hundred and twenty-nine supplementary protection certificates in sixteen countries.

Summary for Impax

International Patents:	81
US Patents:	13
Tradenames:	120
Ingredients:	117
NDAs:	152
Patent Litigation for Impax:	See patent lawsuits for Impax
PTAB Cases with Impax as petitioner:	See PTAB cases with Impax as petitioner

Drugs and US Patents for Impax

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	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	077756-001	Apr 9, 2008	AN	RX	No	No
Impax Labs	DIGOXIN	digoxin	TABLET;ORAL	078556-001	Jul 20, 2009	AB	RX	No	No
Impax Labs	PIPERAZINE CITRATE	piperazine citrate	TABLET;ORAL	080874-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090024-002	Feb 3, 2009		DISCN	No	No
Impax Labs	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076985-001	Sep 13, 2005		DISCN	No	No

Expired US Patents for Impax

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	5,665,071
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	5,665,071

Paragraph IV (Patent) Challenges for IMPAX drugs

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

International Patents for Impax Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03101432
Japan	5783725
Canada	2711014
Australia	2003247409
Taiwan	200724182

Supplementary Protection Certificates for Impax Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0716606	6/2002	Austria		PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2712622	122017000006	Germany		PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Impact
• Impax
• Impax Labs
• Impax Labs Inc
• Impax Pharms