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Generated: June 25, 2018

DrugPatentWatch Database Preview

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 eighty-four patent family members in forty countries.

There are seventeen drug master file entries for dexlansoprazole. Three suppliers are listed for this compound.
Pharmacology for dexlansoprazole
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for dexlansoprazole
Synonyms for dexlansoprazole
(+)-(R)-Lansoprazole
(+)-2-((R)-{(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl}sulfinyl)-1H-benzimidazole
(+)-lansoprazol
(r)-(+)-lansoprazole
(R)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl)-1H-benzimidazole
(R)-2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1H-benzo[d]imidazole
(R)-2-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-2-YL)METHYLSULFINYL)-1H-BENZO[D]IMIDAZOLE
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole
(R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole
(R)-Lansoprazole
138530-94-6
1H-Benzimidazole, 2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-
2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazole
2-[(R)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1H-benzimidazole
2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanesulfinyl]-1H-1,3-benzodiazole
2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl]-1H-1,3-benzodiazole
3B1-001176
AB01563023_01
AB01563023_02
AC-26449
AK170558
AKOS025290765
AN-31849
AS-18086
CCG-213301
CHEBI:135931
CHEMBL1201863
CS-2820
D06YYD
D08903
DB05351
dexilant
Dexilant Solutab
Dexlansoprazole (INN/USAN)
Dexlansoprazole [USAN:INN]
Dexlansoprazole sesquihydrate
FT-0670721
GTPL5487
HE065042
HMS3652C14
HY-13662B
Kapidex
KS-00000PLS
KS-1075
MFCD13196699
MJIHNNLFOKEZEW-RUZDIDTESA-N
MolPort-002-885-834
PB33188
Q-1374
R- -Lansoprazole
R-(+)-LANSOPRAZOLE
r-lansoprazole
s4099
SC-71768
SCHEMBL44975
T 168390
T-168390
TAK 390
TAK-390
TAK-390MR
UNII-0K5C5T2QPG component MJIHNNLFOKEZEW-RUZDIDTESA-N
UNII-UYE4T5I70X
UYE4T5I70X
W0028
ZINC599734

US Patents and Regulatory Information for dexlansoprazole

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 SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DEXILANT SOLUTAB dexlansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056-001 Jan 26, 2016 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for dexlansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
9,889,125 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy ➤ Sign Up
9,889,152 Multiple PPI dosage form ➤ Sign Up
7,339,064 Benzimidazole compound crystal ➤ Sign Up
7,569,697 Benzimidazole compound crystal ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dexlansoprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014014,C1129088 Lithuania ➤ Sign Up PRODUCT 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
90004-7 Sweden ➤ Sign Up PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
14/008 Ireland ➤ Sign Up PRODUCT 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
1129088/01 Switzerland ➤ Sign Up PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
UBS
Chubb
Merck
Queensland Health
Daiichi Sankyo
Deloitte
Fuji
Argus Health

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