DEXILANT Drug Patent Profile
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Which patents cover Dexilant, and what generic alternatives are available?
Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty patent family members in thirty-one countries.
The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexilant
A generic version of DEXILANT was approved as dexlansoprazole by ENDO OPERATIONS on April 19th, 2017.
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Summary for DEXILANT
| International Patents: | 120 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 31 |
| Patent Applications: | 515 |
| Drug Prices: | Drug price information for DEXILANT |
| Drug Sales Revenues: | Drug sales revenues for DEXILANT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEXILANT |
| What excipients (inactive ingredients) are in DEXILANT? | DEXILANT excipients list |
| DailyMed Link: | DEXILANT at DailyMed |
Recent Clinical Trials for DEXILANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Karachi | Phase 1 |
| SAMI Pharmaceutical, Karachi Pakistan | Phase 1 |
| Taipei Veterans General Hospital, Taiwan | N/A |
Pharmacology for DEXILANT
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
Paragraph IV (Patent) Challenges for DEXILANT
| 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 DEXILANT
DEXILANT is protected by seven US patents.
Patents protecting DEXILANT
Multiple PPI dosage form
Patent Number: ⤷ Sign Up
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Controlled release preparation
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Controlled release preparation
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Method for producing granules
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Method for producing granules
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Patent Expiration: ⤷ Sign Up
Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS
Multiple PPI dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | ||
| 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 | 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 | ||
| >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 DEXILANT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 | 022287-002 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DEXILANT
See the table below for patents covering DEXILANT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1080378 | CONTROLLED RELEASE PREPARATION | ⤷ Sign Up |
| Taiwan | I290922 | ⤷ Sign Up | |
| Canada | 2784881 | PROCEDE DE FABRICATION DE GRANULES (METHOD FOR PRODUCING GRANULES) | ⤷ Sign Up |
| Denmark | 1459737 | ⤷ Sign Up | |
| Australia | 5247800 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEXILANT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1129088 | 122014000036 | Germany | ⤷ Sign Up | PRODUCT 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 |
| 1129088 | C 2014 021 | Romania | ⤷ Sign Up | PRODUCT NAME: DEXLANSOPRAZOL(R)-2-([3-METIL-4-(2,2,2-TRIFLUOROETOXI)PIRIDIN-2-IL]METILSULFINIL)-1H-BENZIMIDAZOL; NATIONAL AUTHORISATION NUMBER: RO6090/2014/01, RO6090/2014/02; DATE OF NATIONAL AUTHORISATION: 20140120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE 47911; DATE OF FIRST AUTHORISATION IN EEA: 20130919 |
| 1129088 | PA2014014,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 |
| 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 |
| 1129088 | C01129088/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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