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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
QuintilesIMS
UBS
Accenture
Baxter
Merck
Covington
Queensland Health

Generated: December 15, 2018

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Impax Labs Company Profile

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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-three approved drugs.

There are nine US patents protecting IMPAX LABS drugs. There are three tentative approvals on IMPAX LABS drugs.

There are thirty-five patent family members on IMPAX LABS drugs in fourteen countries and eighty-seven supplementary protection certificates in thirteen countries.

Summary for Impax Labs
International Patents:35
US Patents:9
Tradenames:110
Ingredients:109
NDAs:143

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 Inc MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 090024-003 Feb 3, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079087-004 Dec 21, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079087-001 Jun 14, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc CARVEDILOL PHOSPHATE carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 204717-003 May 7, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077248-002 Mar 31, 2006 AB RX No No ➤ Try a Free Trial ➤ Try a Free 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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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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 Belgium ➤ Try a Free Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
/2012 Austria ➤ Try a Free Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
00159 Netherlands ➤ Try a Free Trial PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
00524 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
2011 00026 Denmark ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
QuintilesIMS
Harvard Business School
Express Scripts
Chubb
Medtronic
Argus Health
McKinsey
Cerilliant

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.