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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Baxter
Harvard Business School
Covington
Teva
Johnson and Johnson
Accenture
Cantor Fitzgerald
Boehringer Ingelheim
Cipla

Generated: July 25, 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-one 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-six patent family members on IMPAX LABS drugs in seventeen countries.

Summary for Applicant: Impax Labs

Patents:11
Tradenames:115
Ingredients:112
NDAs:151
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL076852-002Feb 16, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
ASPIRIN AND DIPYRIDAMOLE
aspirin; dipyridamole
CAPSULE, EXTENDED RELEASE;ORAL206964-001Jan 18, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
LETROZOLE
letrozole
TABLET;ORAL091638-001Jun 3, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
METHYLTESTOSTERONE
methyltestosterone
TABLET;ORAL080767-002Approved Prior to Jan 1, 1982BPRXNoNo► 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
South Africa200800888► Subscribe
Taiwan200724182► Subscribe
European Patent Office1848490► Subscribe
China101850143► Subscribe
South Africa200704516► 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
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
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
C/GB08/040United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
C/GB02/033United Kingdom► SubscribePRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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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:

Medtronic
Merck
Deloitte
Covington
Dow
Express Scripts
QuintilesIMS
Farmers Insurance
McKesson
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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