Impax Labs Company Profile

What is the competitive landscape for IMPAX LABS, and what generic alternatives to IMPAX LABS drugs are available?

IMPAX LABS has one hundred and forty-one approved drugs.

There are nine US patents protecting IMPAX LABS drugs. There is one tentative approval on IMPAX LABS drugs.

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

Summary for Impax Labs

International Patents:	38
US Patents:	9
Tradenames:	108
Ingredients:	107
NDAs:	141

Drugs and US Patents for Impax Labs

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	METHYLTESTOSTERONE	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	084287-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs Inc	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	079108-002	Aug 5, 2015	AB	RX	No	No
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-002	Oct 20, 2015		DISCN	No	No
Impax Labs Inc	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065331-001	Aug 9, 2007	AP	RX	No	No
Impax Labs	PROPOXYPHENE HYDROCHLORIDE	propoxyphene hydrochloride	CAPSULE;ORAL	083317-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs Inc	URSODIOL	ursodiol	TABLET;ORAL	200826-002	Dec 23, 2011		DISCN	No	No
Impax Labs	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	083607-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Impax Labs

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	7,094,427
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015	7,094,427
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015	7,094,427
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015	7,094,427

Paragraph IV (Patent) Challenges for IMPAX LABS 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 Labs Drugs

Country	Patent Number	Estimated Expiration
Israel	248520
Japan	6328205
Australia	2008343787
Taiwan	200706182
South Korea	101752080
New Zealand	602302
Japan	2017014295

Supplementary Protection Certificates for Impax Labs Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
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
2316456	SPC/GB17/078	United Kingdom		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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2498758	PA2020003	Lithuania		PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
2498758	301040	Netherlands		PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116

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