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Serving 500+ biopharmaceutical companies globally:

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Generated: September 20, 2017

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 fifty-two 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-seven patent family members on IMPAX LABS drugs in seventeen countries.

Summary for Applicant: Impax Labs

Patents:11
Tradenames:116
Ingredients:113
NDAs:152
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;ORAL203312-003Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076731-003Nov 19, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
TWINJECT 0.3
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-001May 30, 2003DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-004Jan 7, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL075710-002Feb 6, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL071973-001Apr 6, 1988ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
METHYLTESTOSTERONE
methyltestosterone
TABLET;ORAL080767-002Approved Prior to Jan 1, 1982BPRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
FENOFIBRIC ACID
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL200264-001Sep 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
PREDNISONE
prednisone
TABLET;ORAL080782-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL078484-002May 27, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Impax Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 2009► Subscribe► Subscribe
Impax Labs Inc
ADRENACLICK
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-004Nov 25, 2009► Subscribe► Subscribe
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Paragraph IV activity for IMPAX LABS drugs

Drugname Dosage Strength Tradename Submissiondate
carbidopa and levodopa
Extended-release Capsules23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg
RYTARY
6/24/2015
carbidopa and levodopa
Extended-release Capsules61.25 mg/245 mg
RYTARY
6/10/2015
omeprazole
Delayed-release Tablets20 mg
OMEPRAZOLE
6/3/2015

Non-Orange Book 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
7,927,303Medicine injection devices and methods► Subscribe
8,187,224Methods performed by medicine injection apparatuses► Subscribe
7,931,618Apparatuses and methods for injecting medicines to a desired depth► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Impax Labs Drugs

Country Document Number Estimated Expiration
China101910113► Subscribe
Israel248520► Subscribe
World Intellectual Property Organization (WIPO)2006073729► Subscribe
Japan2005528430► Subscribe
Hong Kong1215386► Subscribe
Russian Federation2008103666► Subscribe
European Patent Office1848490► Subscribe
South Africa200800888► Subscribe
Norway20073489► Subscribe
World Intellectual Property Organization (WIPO)2006062997► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Impax Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C0028France► SubscribePRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
C0062France► SubscribePRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
12/008Ireland► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
13/055Ireland► SubscribePRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
00140Netherlands► SubscribePRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Fuji
Chubb
Baxter
Accenture
Federal Trade Commission
Healthtrust
Citi
McKesson
AstraZeneca
Dow

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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