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Serving leading biopharmaceutical companies globally:

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Generated: December 14, 2017

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Dexlansoprazole - Generic Drug Details

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What are the generic sources for dexlansoprazole and what is the scope of dexlansoprazole freedom to operate?

Dexlansoprazole
is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and Par Pharm Inc, and is included in three NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has two hundred and forty-three patent family members in thirty-nine countries and six supplementary protection certificates in five countries.

There are fifteen drug master file entries for dexlansoprazole. Three suppliers are listed for this compound.

Summary for dexlansoprazole

Pharmacology for dexlansoprazole

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for dexlansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANT SOLUTABdexlansoprazoleTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaDEXILANT SOLUTABdexlansoprazoleTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaDEXILANT SOLUTABdexlansoprazoleTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL208056-001Jan 26, 2016DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dexlansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 2009► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009► Subscribe► Subscribe
Takeda Pharms UsaDEXILANTdexlansoprazoleCAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dexlansoprazole

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
7,339,064Benzimidazole compound crystal► Subscribe
8,884,019Benzimidazole compound crystal► Subscribe
8,030,333Benzimidazole compound crystal► Subscribe
8,552,198Benzimidazole compound crystal► Subscribe
7,737,282Benzimidazole compound crystal► Subscribe
7,569,697Benzimidazole compound crystal► Subscribe
7,070,805Rapidly disintegrable solid preparation► 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 Ingredient: dexlansoprazole

Country Document Number Estimated Expiration
Taiwan201125563► Subscribe
Japan5563735► Subscribe
European Patent Office1121103► Subscribe
China1310613► Subscribe
Canada2737851► Subscribe
World Intellectual Property Organization (WIPO)0244167► Subscribe
South Korea20050072108► Subscribe
Portugal1977751► Subscribe
Hong Kong1035501► Subscribe
Slovenia1129088► 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 Tradename: DEXLANSOPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/008Ireland► SubscribePRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
1129088/01Switzerland► SubscribePRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
90004-7Sweden► SubscribePRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
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
2014014,C1129088Lithuania► SubscribePRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
2014014Lithuania► SubscribePRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Deloitte
Cipla
McKinsey
Fish and Richardson
Daiichi Sankyo
Accenture

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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