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Generated: July 25, 2017
Which patents cover Dexilant, and what generic Dexilant alternatives are available?
Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are twenty-one patents protecting this drug and two Paragraph IV challenges.| Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 28 |
| Clinical Trials: see list | 16 |
| Patent Applications: see list | 103 |
| Drug Prices: | see details |
| DailyMed Link: | DEXILANT at DailyMed |
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
| 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 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Takeda Pharms Usa | DEXILANT SOLUTAB | dexlansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208056-001 | Jan 26, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| dexlansoprazole | Delayed-release Capsule | 30 mg | Dexilant | 11/30/2010 |
| dexlansoprazole | Capsule | 60 mg | Dexilant | 8/25/2010 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,884,019 | Benzimidazole compound crystal | ► Subscribe | |||||||||||||||||||||||||||
| 7,339,064 | Benzimidazole compound crystal | ► Subscribe | |||||||||||||||||||||||||||
| 7,737,282 | Benzimidazole compound crystal | ► Subscribe | |||||||||||||||||||||||||||
| 8,552,198 | Benzimidazole compound crystal | ► Subscribe | |||||||||||||||||||||||||||
| 8,030,333 | Benzimidazole compound crystal | ► 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Denmark | 1129088 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 079473 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1768668 | ► Subscribe | |||||||||||||||||||||||||||
| Peru | 00762009 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2001058990 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014014,C1129088 | Lithuania | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2014000036 | Germany | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2014014 | Lithuania | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919 | ||||||||||||||||||||||||||
| 14/008 | Ireland | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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