Impax Company Profile

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IMPAX has one hundred and fifty-two approved drugs.

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

There are twenty-five patent family members on IMPAX drugs in twelve countries and one hundred and thirty-seven supplementary protection certificates in sixteen countries.

International Patents:	25
US Patents:	8
Tradenames:	119
Ingredients:	116
NDAs:	152
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	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	203184-001	Sep 15, 2015	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Impax Pharms	ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040368-001	Jun 23, 2000		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
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	7,094,427	⤷ Try a Trial
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015	7,094,427	⤷ Try a Trial
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	5,665,071	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Delayed-release Tablets	20 mg	➤ Subscribe	2015-06-03
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SPC/GB98/031	United Kingdom	⤷ Try a Trial	PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
1602370	2009/010	Ireland	⤷ Try a Trial	PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
2316456	C 2017 047	Romania	⤷ Try a Trial	PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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