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Serving 500+ biopharmaceutical companies globally:

Merck
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Novartis
QuintilesIMS
Healthtrust
Cerilliant
Moodys
Covington
US Army
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Generated: August 23, 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-six 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.

Summary for Applicant: Impax Labs Inc

Patents:11
Tradenames:48
Ingredients:46
NDAs:56
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;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
NABUMETONE
nabumetone
TABLET;ORAL075189-001May 26, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-003Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Impax Labs Inc
ANASTROZOLE
anastrozole
TABLET;ORAL091242-001May 31, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-001Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► 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
European Patent Office2234963► Subscribe
Russian Federation2008103666► Subscribe
Russian Federation2007124153► Subscribe
World Intellectual Property Organization (WIPO)2006062788► Subscribe
European Patent Office1824560► 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
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
C/GB95/010United Kingdom► SubscribePRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
C/GB12/028United Kingdom► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
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
C/GB98/031United Kingdom► SubscribePRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
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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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Serving 500+ biopharmaceutical companies globally:

Fuji
Moodys
Cantor Fitzgerald
Johnson and Johnson
Harvard Business School
QuintilesIMS
UBS
Fish and Richardson
Citi
Baxter

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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