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Serving leading biopharmaceutical companies globally:

Dow
Argus Health
McKesson
Johnson and Johnson
UBS
Accenture
Cantor Fitzgerald
Citi
McKinsey
US Army

Generated: February 22, 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-seven approved drugs.

There are eleven US patents protecting IMPAX LABS drugs and there have been three Paragraph IV challenges on IMPAX LABS drugs in the past three years. 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-one supplementary protection certificates in thirteen countries.

Summary for Impax Labs
International Patents:78
US Patents:11
Tradenames:113
Ingredients:110
NDAs:147

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 ACITRETIN acitretin CAPSULE;ORAL 202552-003 Dec 23, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 060469-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc NABUMETONE nabumetone TABLET;ORAL 075189-001 May 26, 2000 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc ISOSORBIDE DINITRATE isosorbide dinitrate TABLET, EXTENDED RELEASE;ORAL 040723-001 Mar 17, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs SULFISOXAZOLE sulfisoxazole TABLET;ORAL 080109-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs AMINOPHYLLINE aminophylline TABLET, DELAYED RELEASE;ORAL 084575-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202238-001 Oct 20, 2015 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs BACLOFEN baclofen TABLET;ORAL 077971-002 Oct 26, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852-001 Feb 16, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 8,377,474 ➤ Try a Free Trial Y ➤ 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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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 ➤ Try a Free Trial
Impax Labs Inc ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 5,665,071 ➤ Try a Free Trial
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 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
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 6/3/2015

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

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International Patents for Impax Labs Drugs

Supplementary Protection Certificates for Impax Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014026 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2002 Austria ➤ Try a Free Trial PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
2008000046 Germany ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
C/GB01/006 United Kingdom ➤ Try a Free Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
/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
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2014026,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
496 Luxembourg ➤ Try a Free Trial 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
C0012 France ➤ Try a Free Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1506211/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
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:

Moodys
Argus Health
Queensland Health
Cantor Fitzgerald
Colorcon
Farmers Insurance
Federal Trade Commission
Fuji
Cipla

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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