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DEXILANT Drug 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 seventeen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and ninety-six patent family members in thirty-five countries.
The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
US ANDA Litigation and Generic Entry Outlook for Dexilant
A generic version of DEXILANT was approved as dexlansoprazole by PAR PHARM INC on April 19th, 2017.
Summary for DEXILANT
| International Patents: | 196 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 50 |
| Clinical Trials: | 17 |
| Patent Applications: | 106 |
| 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 |
| DailyMed Link: | DEXILANT at DailyMed |
Recent Clinical Trials for DEXILANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Taipei Veterans General Hospital, Taiwan | N/A |
| Ramathibodi Hospital | Phase 4 |
| Hikma Pharma,Egypt | Phase 1 |
Pharmacology for DEXILANT
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
Paragraph IV (Patent) Challenges for DEXILANT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DEXILANT | CAPSULE, DELAYED RELEASE;ORAL | dexlansoprazole | 022287 | 2010-11-30 |
US Patents and Regulatory Information for DEXILANT
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | Start Trial | Start Trial |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | Start Trial | Start Trial |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DEXILANT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2258351 | Start Trial |
| Spain | 2426723 | Start Trial |
| Poland | 362801 | Start Trial |
| European Patent Office | 2343289 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DEXILANT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1129088 | C 2014 021 | Romania | Start Trial | 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 | 2014/008 | Ireland | Start Trial | 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 | 2014C/017 | Belgium | Start Trial | PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023 |
| 1129088 | PA2014014,C1129088 | Lithuania | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
