Impax Company Profile

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

IMPAX has one hundred and fifty-one approved drugs.

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

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

Summary for Impax

International Patents:	81
US Patents:	13
Tradenames:	119
Ingredients:	116
NDAs:	151
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	SULFISOXAZOLE	sulfisoxazole	TABLET;ORAL	080109-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs	RESERPINE	reserpine	TABLET;ORAL	009627-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087-005	Jun 14, 2010		RX	No	No
Impax Labs Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205105-001	Jul 28, 2016	AB2	RX	No	No
Impax Labs	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	CAPSULE;ORAL	065005-001	Mar 23, 1999	AB	RX	No	No
Impax Labs Inc	BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	074253-001	Mar 28, 2001	AB	RX	No	No

Expired US Patents for Impax

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015	7,094,427
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	5,665,071
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	7,094,427
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	5,665,071
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015	7,094,427
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015	7,094,427

Paragraph IV (Patent) Challenges for IMPAX drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Extended-release Capsules	61.25 mg/245 mg		2015-06-10

International Patents for Impax Drugs

Country	Patent Number	Estimated Expiration
Japan	5783725
Taiwan	200724182
San Marino	P200700023
South Africa	200704515
Spain	2804348
Mexico	2007006251

Supplementary Protection Certificates for Impax Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624

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