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Serving leading biopharmaceutical companies globally:

UBS
Argus Health
Covington
US Department of Justice
Harvard Business School
McKinsey
QuintilesIMS
Johnson and Johnson
Cerilliant
Chinese Patent Office

Generated: October 16, 2017

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-nine 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-seven patent family members on IMPAX LABS INC drugs in seventeen countries and eighteen supplementary protection certificates in five countries.

Summary for Applicant: Impax Labs Inc

International Patents:77
US Patents:11
Tradenames:50
Ingredients:48
NDAs:59
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
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL076731-003Nov 19, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-004Jan 7, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride
INJECTABLE;INJECTION065331-002Aug 9, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
EZETIMIBE AND SIMVASTATIN
ezetimibe; simvastatin
TABLET;ORAL201890-004Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
HYDROCORTISONE
hydrocortisone
TABLET;ORAL040646-003Mar 30, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride
TABLET;ORAL074253-003Mar 13, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL079108-005Nov 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
METAXALONE
metaxalone
TABLET;ORAL040486-001Feb 27, 2015RXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Impax Labs Inc

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 INC 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

Non-Orange Book 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
7,927,303Medicine 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 Inc Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006063015► Subscribe
South Africa200704516► Subscribe
South Korea20130113533► Subscribe
China101072595► Subscribe
Japan5783725► Subscribe
Japan2008522668► Subscribe
China101910113► Subscribe
Taiwan200633730► Subscribe
Canada2826821► Subscribe
Japan6033373► 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 Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
C0026France► SubscribePRODUCT NAME: RALTEGRAVIR OU L(UN DE SES SELS PHARMACEUTIQUEMENT ACCCEPTABLES EN PARTICULIER UN SEL DE POTASSIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/07/436/001 DU 20071220; REGISTRATION NO/DATE AT EEC: EU/1/07/436/001 DU 20071220
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
C/GB08/020United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
2017 00030Denmark► SubscribePRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
C/GB96/004United Kingdom► SubscribePRODUCT NAME: ANASTROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT; REGISTRATION NO/DATE: UK 12619/0106 19950811
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
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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 leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Medtronic
Chubb
Dow
US Army
Moodys
McKinsey
Covington
Mallinckrodt

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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