Duexis is a drug owned by Horizon Medicines Llc. It is protected by 6 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2026. Details of Duexis's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8067451 | Methods and medicaments for administration of ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8501228 | Stable compositions of famotidine and ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8067033 | Stable compositions of famotidine and ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8318202 | Stable compositions of famotidine and ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8309127 | Stable compositions of famotidine and ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8449910 | Stable compositions of famotidine and ibuprofen |
Jul, 2026
(1 year, 2 months from now) | Active |
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 Duexis's patents.
Latest Legal Activities on Duexis's Patents
Given below is the list of recent legal activities going on the following patents of Duexis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 15 Jul, 2024 | US8318202 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US8309127 (Litigated) |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 28 May, 2023 | US8067033 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 28 May, 2023 | US8067451 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Feb, 2021 | US8501228 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Nov, 2020 | US8449910 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 May, 2020 | US8318202 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 May, 2020 | US8309127 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 29 May, 2019 | US8067033 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 29 May, 2019 | US8067451 |
FDA has granted several exclusivities to Duexis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Duexis, 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 Duexis.
Exclusivity Information
Duexis holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Duexis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Apr 23, 2014 |
US patents provide insights into the exclusivity only within the United States, but Duexis 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 Duexis's family patents as well as insights into ongoing legal events on those patents.
Duexis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Duexis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duexis Generic API suppliers:
Famotidine; Ibuprofen is the generic name for the brand Duexis. 6 different companies have already filed for the generic of Duexis, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Duexis's generic
How can I launch a generic of Duexis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Duexis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Duexis'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 Duexis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 800 mg/26.6 mg | 06 Dec, 2011 | 1 | 18 Jul, 2026 | Extinguished |
About Duexis
Duexis is a drug owned by Horizon Medicines Llc. It is used for relieving symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of upper gastrointestinal ulcers in patients taking ibuprofen for these conditions. Duexis uses Famotidine; Ibuprofen as an active ingredient. Duexis was launched by Horizon in 2011.
Approval Date:
Duexis was approved by FDA for market use on 23 April, 2011.
Active Ingredient:
Duexis uses Famotidine; Ibuprofen as the active ingredient. Check out other Drugs and Companies using Famotidine; Ibuprofen ingredient
Treatment:
Duexis is used for relieving symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of upper gastrointestinal ulcers in patients taking ibuprofen for these conditions.
Dosage:
Duexis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |