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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Harvard Business School
Julphar
Express Scripts
Covington
Queensland Health
Chubb
UBS

Generated: August 16, 2018

DrugPatentWatch Database Preview

Impax Labs Company Profile

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What is the competitive landscape for IMPAX LABS, and when can generic versions of IMPAX LABS drugs launch?

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

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

There are seventy-eight patent family members on IMPAX LABS drugs in eighteen countries and eighty-seven supplementary protection certificates in thirteen countries.

Summary for Impax Labs
International Patents:78
US Patents:12
Tradenames:113
Ingredients:110
NDAs:144

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 HYDROCORTISONE hydrocortisone TABLET;ORAL 080781-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs PRIMIDONE primidone TABLET;ORAL 040717-002 Feb 12, 2008 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs THYROGLOBULIN thyroglobulin TABLET;ORAL 080151-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc HYDROCORTISONE hydrocortisone TABLET;ORAL 040646-003 Mar 30, 2007 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes 9,089,608 ➤ Sign Up Y ➤ 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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Expired US Patents for Impax Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009 5,665,071 ➤ Sign Up
Impax Labs Inc ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 5,665,071 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for IMPAX LABS drugs
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

Non-Orange Book US Patents for Impax Labs

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,927,303 Medicine injection devices and methods ➤ Sign Up
8,187,224 Methods performed by medicine injection apparatuses ➤ Sign Up
7,931,618 Apparatuses and methods for injecting medicines to a desired depth ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Impax Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
C/GB09/024 United Kingdom ➤ Sign Up PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
C/GB02/011 United Kingdom ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
/2008 Austria ➤ Sign Up PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
C0023 France ➤ Sign Up PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811
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
Farmers Insurance
McKesson
Cipla
Fuji
Johnson and Johnson
Mallinckrodt
Medtronic
Chinese Patent Office

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