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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Accenture
Medtronic
Harvard Business School
UBS
Julphar
Federal Trade Commission
Cerilliant
Covington

Generated: December 12, 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-eight patent family members on IMPAX LABS INC drugs in eighteen countries and twenty-five supplementary protection certificates in eight countries.

Summary for Impax Labs Inc

International Patents:78
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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Impax Labs IncLAMOTRIGINElamotrigineTABLET, ORALLY DISINTEGRATING;ORAL200828-003Jul 15, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncHYDROXYZINE PAMOATEhydroxyzine pamoateCAPSULE;ORAL040156-002Jul 15, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncALENDRONATE SODIUMalendronate sodiumTABLET;ORAL075710-004Feb 6, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncLAMOTRIGINElamotrigineTABLET, ORALLY DISINTEGRATING;ORAL200828-001Jul 15, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncDEXEDRINEdextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL017078-003Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncTWINJECT 0.3epinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-001May 30, 2003DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Impax Labs IncGUANFACINE HYDROCHLORIDEguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL202238-002Oct 20, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncMIRTAZAPINEmirtazapineTABLET, ORALLY DISINTEGRATING;ORAL076901-003Jun 28, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncMORPHINE SULFATEmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL200411-004Apr 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncRYTARYcarbidopa; levodopaCAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► 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 IncADRENACLICKepinephrineINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020800-003Nov 25, 2009► Subscribe► Subscribe
Impax Labs IncADRENACLICKepinephrineINJECTABLE;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 levodopaExtended-release Capsules23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mgRYTARY6/24/2015
carbidopa and levodopaExtended-release Capsules61.25 mg/245 mgRYTARY6/10/2015

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
Russian Federation2008103666► Subscribe
BrazilPI0518415► Subscribe
Norway20073489► Subscribe
San MarinoP200700023► Subscribe
Mexico2010007207► Subscribe
Japan5783725► Subscribe
Mexico2007006251► Subscribe
Canada2826821► Subscribe
South Korea101451564► Subscribe
New Zealand554828► 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
C0023France► SubscribePRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811
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
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
0716606/01Switzerland► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
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
2002Austria► SubscribePRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
C0011France► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
00080Netherlands► SubscribePRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
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/GB10/012United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
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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 leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Dow
Chinese Patent Office
UBS
Deloitte
US Army
Boehringer Ingelheim
Moodys
Cantor Fitzgerald

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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