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Serving leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Merck
Deloitte
Teva
Daiichi Sankyo
QuintilesIMS
Harvard Business School
Baxter
UBS

Generated: February 21, 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-three approved drugs.

There are eleven US patents protecting IMPAX LABS INC drugs and there have been two Paragraph IV challenges on IMPAX LABS INC drugs in the past three years. 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 seventeen supplementary protection certificates in seven countries.

Summary for Impax Labs Inc
International Patents:78
US Patents:11
Tradenames:46
Ingredients:44
NDAs:53

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 MIRTAZAPINE mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 076901-001 Jun 28, 2005 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073671-001 Jan 28, 1993 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 9,089,607 ➤ Sign Up Y ➤ Sign Up
Impax Labs Inc HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 040156-002 Jul 15, 1996 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No ➤ Sign Up ➤ Sign Up
Impax Labs Inc DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 077122-001 Jan 25, 2006 AB RX No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No 8,377,474 ➤ Sign Up Y ➤ Sign Up
Impax Labs Inc URSODIOL ursodiol CAPSULE;ORAL 077895-001 Jul 27, 2006 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040457-001 Dec 26, 2002 DISCN No No ➤ Sign Up ➤ Sign Up
Impax Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-004 Apr 26, 2017 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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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 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg ➤ Subscribe 6/24/2015
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 6/10/2015

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

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International Patents for Impax Labs Inc Drugs

Supplementary Protection Certificates for Impax Labs Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/004 United Kingdom ➤ Sign Up PRODUCT NAME: ANASTROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT; REGISTRATION NO/DATE: UK 12619/0106 19950811
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
C0055 France ➤ Sign Up PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811
00428 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
C/GB02/011 United Kingdom ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
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
0716606/01 Switzerland ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
/2009 Austria ➤ Sign Up PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
2002 Austria ➤ Sign Up PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
C0009 Belgium ➤ Sign Up PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
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:

Baxter
US Department of Justice
Express Scripts
Accenture
Merck
Cipla
Chubb
Fish and Richardson
Argus Health

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.

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