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Generated: September 25, 2017

DrugPatentWatch Database Preview

Takeda Pharms Usa Company Profile

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What is the competitive landscape for TAKEDA PHARMS USA, and when can generic versions of TAKEDA PHARMS USA drugs launch?

TAKEDA PHARMS USA has seventeen approved drugs.

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

There are one thousand and sixty-five patent family members on TAKEDA PHARMS USA drugs in fifty-nine countries.

Summary for Applicant: Takeda Pharms Usa

Patents:82
Tradenames:17
Ingredients:14
NDAs:17
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
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-004Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
OMONTYS PRESERVATIVE FREE
peginesatide acetate
SOLUTION;INTRAVENOUS, SUBCUTANEOUS202799-003Mar 27, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-002Jan 25, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
OMONTYS PRESERVATIVE FREE
peginesatide acetate
SOLUTION;INTRAVENOUS, SUBCUTANEOUS202799-006Mar 27, 2012DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-003Sep 30, 2013DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Takeda Pharms Usa

Paragraph IV activity for TAKEDA PHARMS USA drugs

Drugname Dosage Strength Tradename Submissiondate
alogliptin and metformin hydrochloride
Tablets12.5 mg/500 mg and 12.5 mg/1000 mg
KAZANO
1/25/2017
alogliptin
Tablets6.25 mg, 12.5 mg and 25 mg
NESINA
1/25/2017
febuxostat
Tablets40 mg and 80 mg
ULORIC
2/13/2013
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 Pharms Usa

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
8,110,567Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
7,683,053Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
7,148,238Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
7,138,407Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
9,101,626Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof► Subscribe
7,795,428Dipeptidyl peptidase inhibitors► Subscribe
6,288,090 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 Pharms Usa Drugs

Country Document Number Estimated Expiration
Eurasian Patent Organization017058► Subscribe
World Intellectual Property Organization (WIPO)03029232► Subscribe
Argentina054238► Subscribe
New Zealand552592► Subscribe
Slovakia283970► Subscribe
Canada2338792► Subscribe
Colombia5700740► Subscribe
China1713897► Subscribe
Taiwan201129553► Subscribe
Spain2328308► 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 Pharms Usa Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 5006-2014Slovakia► SubscribePRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
334Luxembourg► SubscribeCERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
14/012Ireland► SubscribePRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
00706Netherlands► SubscribePRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
C/GB10/019United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023.
/2010Austria► SubscribePRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
2014011Lithuania► SubscribePRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919
0140037 00152Estonia► SubscribePRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
00640Netherlands► SubscribePRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
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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:

Dow
Fuji
Novartis
Baxter
Daiichi Sankyo
Chubb
Colorcon
US Department of Justice
Federal Trade Commission
Boehringer Ingelheim

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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