Dexilant is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 25 US drug patents filed from 2013 to 2016. Out of these, 12 drug patents are active and 13 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 05, 2032. Details of Dexilant's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9145389 | Benzimidazole compound crystal |
Jun, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9233103 | Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy |
Mar, 2032
(7 years from now) | Active |
|
US8173158 (Pediatric) | Methods of treating gastrointestinal disorders independent of the intake of food |
Sep, 2030
(5 years from now) | Active |
| US8173158 | Methods of treating gastrointestinal disorders independent of the intake of food |
Mar, 2030
(5 years from now) | Active |
| US8871273 | Method for producing granules |
Jan, 2028
(3 years from now) | Active |
|
US8105626 (Pediatric) | Granules containing acid-unstable chemical in large amount |
Mar, 2027
(2 years from now) | Active |
|
US7790755 (Pediatric) | Controlled release preparation |
Feb, 2027
(2 years from now) | Active |
| US8105626 | Granules containing acid-unstable chemical in large amount |
Sep, 2026
(1 year, 8 months from now) | Active |
| US7790755 | Controlled release preparation |
Aug, 2026
(1 year, 7 months from now) | Active |
|
US8461187 (Pediatric) | Multiple PPI dosage form |
Jul, 2026
(1 year, 6 months from now) | Active |
| US9011926 | Method for producing granules |
Feb, 2026
(1 year, 1 month from now) | Active |
| US8461187 | Multiple PPI dosage form |
Jan, 2026
(1 year, 20 days from now) | Active |
| US9238029 | Multiple PPI dosage form |
Jan, 2026
(1 year, 20 days from now) | Active |
|
US8784885 (Pediatric) | Controlled release preparation |
Apr, 2024
(8 months ago) |
Expired
|
|
US8722084 (Pediatric) | Controlled release preparation |
Apr, 2024
(8 months ago) |
Expired
|
| US8784885 | Controlled release preparation |
Oct, 2023
(1 year, 2 months ago) |
Expired
|
| US8722084 | Controlled release preparation |
Oct, 2023
(1 year, 2 months ago) |
Expired
|
|
US6462058 (Pediatric) | Benzimidazole compound crystal |
Dec, 2020
(4 years ago) |
Expired
|
|
US6939971 (Pediatric) | Benzimidazole compound crystal |
Dec, 2020
(4 years ago) |
Expired
|
|
US7285668 (Pediatric) | Process for the crystallization of (R)- or (S)-lansoprazole |
Dec, 2020
(4 years ago) |
Expired
|
|
US6664276 (Pediatric) | Benzimidazole compound crystal |
Dec, 2020
(4 years ago) |
Expired
|
| US6664276 | Benzimidazole compound crystal |
Jun, 2020
(4 years ago) |
Expired
|
| US7285668 | Process for the crystallization of (R)- or (S)-lansoprazole |
Jun, 2020
(4 years ago) |
Expired
|
| US6462058 | Benzimidazole compound crystal |
Jun, 2020
(4 years ago) |
Expired
|
| US6939971 | Benzimidazole compound crystal |
Jun, 2020
(4 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dexilant's patents.
Latest Legal Activities on Dexilant's Patents
Given below is the list of recent legal activities going on the following patents of Dexilant.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 06 Nov, 2023 | US9145389 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Oct, 2023 | US8173158 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2023 | US8105626 |
| Maintenance Fee Reminder Mailed Critical | 22 May, 2023 | US9145389 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2022 | US9011926 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Mar, 2022 | US8871273 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Feb, 2022 | US7790755 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jan, 2022 | US8784885 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Dec, 2020 | US8461187 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2019 | US8173158 (Litigated) |
FDA has granted several exclusivities to Dexilant. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dexilant, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Dexilant.
Exclusivity Information
Dexilant holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Dexilant's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 30, 2012 |
| Pediatric Exclusivity(PED) | Jul 30, 2012 |
| New Patient Population(NPP) | Jul 08, 2019 |
Several oppositions have been filed on Dexilant's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Dexilant's generic, the next section provides detailed information on ongoing and past EP oppositions related to Dexilant patents.
Dexilant's Oppositions Filed in EPO
Dexilant has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 02, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP00937235A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10175046A | Jun, 2016 | Aechter, Bernd | Patent maintained as amended |
| EP03754116A | Dec, 2013 | Sanovel IIaç San. ve Tic. A.S. | Patent maintained as amended |
| EP00937235A | Jan, 2009 | Teva Pharmaceutical Industries Ltd. | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Dexilant is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Dexilant's family patents as well as insights into ongoing legal events on those patents.
Dexilant's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dexilant's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 05, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dexilant Generic API suppliers:
Dexlansoprazole is the generic name for the brand Dexilant. 3 different companies have already filed for the generic of Dexilant, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dexilant's generic
How can I launch a generic of Dexilant before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dexilant's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dexilant's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Dexilant -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg | 30 Nov, 2010 | 1 | 02 Aug, 2026 | Extinguished |
Alternative Brands for Dexilant
Dexilant which is used for treating gastrointestinal conditions such as erosive esophagitis and heartburn., has several other brand drugs in the same treatment category and using the same active ingredient (Dexlansoprazole). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexlansoprazole, Dexilant's active ingredient. Check the complete list of approved generic manufacturers for Dexilant
About Dexilant
Dexilant is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating gastrointestinal conditions such as erosive esophagitis and heartburn. Dexilant uses Dexlansoprazole as an active ingredient. Dexilant was launched by Takeda Pharms Usa in 2009.
Can you believe Dexilant received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Dexilant was approved by FDA for market use on 30 January, 2009.
Active Ingredient:
Dexilant uses Dexlansoprazole as the active ingredient. Check out other Drugs and Companies using Dexlansoprazole ingredient
Treatment:
Dexilant is used for treating gastrointestinal conditions such as erosive esophagitis and heartburn.
Dosage:
Dexilant is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 30MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |