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Serving 500+ biopharmaceutical companies globally:

Argus Health
Medtronic
Novartis
Cipla
Fuji
Cerilliant
QuintilesIMS
Covington
Mallinckrodt
Healthtrust

Generated: August 23, 2017

DrugPatentWatch Database Preview

TAKEDA Company Profile

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What is the competitive landscape for TAKEDA, and what generic alternatives to TAKEDA drugs are available?

TAKEDA has twenty-four approved drugs.

There are ninety-two US patents protecting TAKEDA drugs and there have been two Paragraph IV challenges on TAKEDA drugs in the past three years.

There are one thousand two hundred and eighty-nine patent family members on TAKEDA drugs in sixty-six countries.

Summary for Applicant: TAKEDA

Patents:92
Tradenames:25
Ingredients:17
NDAs:24
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-003Sep 30, 2013DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OMONTYS
peginesatide acetate
SOLUTION;INTRAVENOUS, SUBCUTANEOUS202799-008Mar 27, 2012DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Takeda

Paragraph IV activity for TAKEDA drugs

Drugname Dosage Strength Tradename Submissiondate
alogliptin
Tablets6.25 mg, 12.5 mg and 25 mg
NESINA
1/25/2017
alogliptin and metformin hydrochloride
Tablets12.5 mg/500 mg and 12.5 mg/1000 mg
KAZANO
1/25/2017
febuxostat
Tablets40 mg and 80 mg
ULORIC
2/13/2013
ciclesonide
Nasal Spray250 mcg
OMNARIS
2/13/2012
colchicine
Tablets0.6 mg
COLCRYS
12/23/2011
pioglitazone hydrochloride and metformin hydrochloride
Extended-release Tablets15 mg/1000 mg and 30 mg/1000 mg
ACTOPLUS MET XR
9/23/2011
dexlansoprazole
Delayed-release Capsule30 mg
DEXILANT
11/30/2010
dexlansoprazole
Capsule60 mg
DEXILANT
8/25/2010
pioglitazone hydrochloride and glimepiride
Tablets30 mg/2 mg and 30 mg/4 mg
DUETACT
12/22/2009
ramelteon
Tablets8 mg
ROZEREM
7/22/2009
pioglitazone hydrochloride and metformin hydrochloride
Tablets15 mg/500 mg and 15 mg/850 mg
ACTOPLUS MET
3/6/2008
lansoprazole
Delayed-release Orally Disinte15 mg and 30 mg
PREVACID
12/27/2006
lansoprazole
Delayed-release Pellets/Capsul15 mg and 30 mg
PREVACID
12/5/2005

Non-Orange Book Patents for Takeda

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
6,218,409 Pharmaceutical composition► Subscribe
8,110,567Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
6,133,295 Pharmaceutical composition► Subscribe
7,683,053Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
8,552,198Benzimidazole compound crystal► Subscribe
7,906,523Dipeptidyl peptidase inhibitors► Subscribe
9,101,626Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,148,238Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
6,166,042 Pharmaceutical composition► 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 Takeda Drugs

Country Document Number Estimated Expiration
Austria291418► Subscribe
Ukraine105628► Subscribe
China1145783► Subscribe
Morocco29557► Subscribe
World Intellectual Property Organization (WIPO)2009011451► Subscribe
MexicoPA05012316► Subscribe
European Patent Office1852100► Subscribe
Germany69114725► Subscribe
Canada2677193► Subscribe
European Patent Office1436271► 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 Takeda Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00030Denmark► Subscribe
00708Netherlands► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2014000036Germany► SubscribePRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919
397Luxembourg► SubscribePRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
00652Netherlands► SubscribePRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
0140007 00126Estonia► SubscribePRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
1129088/01Switzerland► SubscribePRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
382Luxembourg► Subscribe91382, EXPIRES: 20220424
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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:

Deloitte
McKinsey
US Army
Accenture
Merck
US Department of Justice
Covington
Argus Health
McKesson
Harvard Business School

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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ISSN: 2162-2639

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