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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Julphar
QuintilesIMS
Colorcon
Boehringer Ingelheim
US Department of Justice
Healthtrust
McKesson
Covington

Generated: July 19, 2018

DrugPatentWatch Database Preview

Impax Labs Inc Company Profile

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

IMPAX LABS INC has fifty approved drugs.

There are twelve US patents protecting IMPAX LABS INC drugs. There is one tentative approval on IMPAX LABS INC drugs.

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

Summary for Impax Labs Inc
International Patents:78
US Patents:12
Tradenames:46
Ingredients:44
NDAs:50

Drugs and US Patents for Impax Labs Inc

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 RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 9,089,608 ➤ Sign Up Y ➤ Sign Up
Impax Labs Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090505-002 Dec 28, 2010 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc TWINJECT 0.15 epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-002 May 28, 2004 DISCN No No 7,621,891 ➤ Sign Up Y ➤ 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
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 Inc

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 INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10
➤ Subscribe Extended-release Capsules 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg ➤ Subscribe 2015-06-24

Non-Orange Book US Patents for Impax Labs Inc

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 Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
00428 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
00159 Netherlands ➤ Sign Up PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
00080 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
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:

Healthtrust
Deloitte
AstraZeneca
QuintilesIMS
Teva
Cerilliant
Johnson and Johnson
Julphar
Medtronic

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.