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Last Updated: January 28, 2021

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Impax Labs Company Profile

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Summary for Impax Labs
International Patents:37
US Patents:9
Tradenames:109
Ingredients:108
NDAs:142

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 PIPERAZINE CITRATE piperazine citrate TABLET;ORAL 080874-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Impax Labs MEPROBAMATE meprobamate TABLET;ORAL 014322-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345-001 Feb 18, 2004 AB RX No No   Start Trial   Start Trial
Impax Labs PROBENECID AND COLCHICINE colchicine; probenecid TABLET;ORAL 083720-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Impax Labs Inc RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 075916-001 Nov 2, 2001 DISCN No No   Start Trial   Start Trial
Impax Labs DANTROLENE SODIUM dantrolene sodium CAPSULE;ORAL 076856-002 Mar 1, 2005 AB RX No No   Start Trial   Start Trial
Impax Labs Inc GLYBURIDE glyburide TABLET;ORAL 206079-001 Sep 30, 2015 AB2 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
Paragraph IV (Patent) Challenges for IMPAX LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10
➤ 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

Supplementary Protection Certificates for Impax Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 349 22-2017 Slovakia   Start Trial PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 132017000142109 Italy   Start Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1506211 300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1539166 2013/055 Ireland   Start Trial 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
0236940 SPC/GB97/013 United Kingdom   Start Trial PRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118
0809498 10C0038 France   Start Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Harvard Business School
McKesson
Johnson and Johnson
Moodys

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