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Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
Dow
Colorcon
QuintilesIMS
Daiichi Sankyo
Cipla
Moodys
Chinese Patent Office
Argus Health

Generated: November 21, 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-three 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 and seventy-nine supplementary protection certificates in thirteen countries.

Summary for Impax Labs

International Patents:77
US Patents:11
Tradenames:117
Ingredients:114
NDAs:153
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs
CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride
CAPSULE;ORAL085113-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
COLESTIPOL HYDROCHLORIDE
colestipol hydrochloride
GRANULE;ORAL077277-002May 2, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
DEXEDRINE
dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL017078-001Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
NABUMETONE
nabumetone
TABLET;ORAL075189-002Sep 24, 2001ABRXNoYes► Subscribe► Subscribe► Subscribe
Impax Labs Inc
BUDESONIDE
budesonide
SUSPENSION;INHALATION078404-002Jul 31, 2012ANRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-002Jan 7, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Impax Labs
TRICHLORMETHIAZIDE
trichlormethiazide
TABLET;ORAL083967-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
LAMOTRIGINE
lamotrigine
TABLET, ORALLY DISINTEGRATING;ORAL200828-003Jul 15, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
GLYBURIDE
glyburide
TABLET;ORAL206079-002Sep 30, 2015AB2RXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs Inc
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL071976-001Apr 6, 1988ABRXNoYes► 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
Australia2005314401► Subscribe
Norway20073489► Subscribe
Japan2011507956► Subscribe
South Africa201005309► Subscribe
China101072604► Subscribe
World Intellectual Property Organization (WIPO)2012103130► Subscribe
Taiwan200727928► Subscribe
Israel206756► Subscribe
San MarinoP200700024► Subscribe
Japan2008522668► 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
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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
C0020France► SubscribePRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0028France► SubscribePRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
00677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
C/GB99/008United Kingdom► SubscribePRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
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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:

Queensland Health
Cerilliant
Dow
Harvard Business School
Baxter
Chinese Patent Office
McKesson
Moodys
Argus Health
US Army

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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