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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Cipla
Merck
Cantor Fitzgerald
Queensland Health

Generated: April 20, 2019

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Impax Company Profile

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

IMPAX has one hundred and fifty-one approved drugs.

There are twelve US patents protecting IMPAX drugs. There are four tentative approvals on IMPAX drugs.

There are eighty patent family members on IMPAX drugs in eighteen countries and one hundred supplementary protection certificates in fourteen countries.

Summary for Impax

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 MEPROBAMATE meprobamate TABLET;ORAL 014322-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-001 Jul 28, 2016 AB2 RX No No ➤ Sign Up ➤ Sign Up
Impax Labs DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852-002 Feb 16, 2016 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs PROBENECID AND COLCHICINE colchicine; probenecid TABLET;ORAL 083720-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415-002 Dec 15, 2006 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 200828-004 Jul 15, 2013 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075710-002 Feb 6, 2008 AB RX No No ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for IMPAX 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 Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0764174 SPC/GB04/031 United Kingdom ➤ Sign Up PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
1261586 1290013-0 Sweden ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
1506211 42/2014 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211 92496 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
0454511 99C0009 Belgium ➤ Sign Up PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
1532149 CA 2013 00001 Denmark ➤ Sign Up 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
1412357 DO 77; 5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKinsey
Cipla
Julphar
Covington
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.