DEXLANSOPRAZOLE - Generic Drug Details

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What are the generic sources for dexlansoprazole and what is the scope of patent protection?

Dexlansoprazole is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Endo Operations, Mylan, and Twi Pharms, and is included in five NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has one hundred and fifty-one patent family members in thirty-eight countries.

There are seventeen drug master file entries for dexlansoprazole. Nine suppliers are listed for this compound.

Summary for DEXLANSOPRAZOLE

International Patents:	151
US Patents:	12
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	51
Patent Applications:	881
Drug Prices:	Drug price trends for DEXLANSOPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXLANSOPRAZOLE
What excipients (inactive ingredients) are in DEXLANSOPRAZOLE?	DEXLANSOPRAZOLE excipients list
DailyMed Link:	DEXLANSOPRAZOLE at DailyMed

See drug prices for DEXLANSOPRAZOLE

Recent Clinical Trials for DEXLANSOPRAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
SAMI Pharmaceutical, Karachi Pakistan	Phase 1
University of Karachi	Phase 1
Taipei Veterans General Hospital, Taiwan	N/A

See all DEXLANSOPRAZOLE clinical trials

Pharmacology for DEXLANSOPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE

Anti-Ulcer Agents
Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DEXLANSOPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DEXLANSOPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEXILANT	Delayed-release Capsules	dexlansoprazole	30 mg	022287	1	2010-11-30

US Patents and Regulatory Information for DEXLANSOPRAZOLE

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Glossary

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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;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DEXLANSOPRAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DEXLANSOPRAZOLE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1768668	FORME POSOLOGIQUE A DOSES PPI MULTIPLES (MULTIPLE PPI DOSAGE FORM)	⤷ Sign Up
Mexico	2010009824	PREPARACION SOLIDA DE DESINTEGRACION ORAL. (ORALLY-DISINTEGRATING SOLID PREPARATION.)	⤷ Sign Up
South Africa	200502318	Controlled release preparation	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DEXLANSOPRAZOLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	2014/008	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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