Xartemis Xr is a drug owned by Mallinckrodt Inc. It is protected by 13 US drug patents filed from 2014 to 2016. Out of these, 12 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 16, 2032. Details of Xartemis Xr'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). | |||
| US9050335 | Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia |
May, 2032
(7 years from now) | Active |
| US8741885 | Gastric retentive extended release pharmaceutical compositions |
May, 2032
(7 years from now) | Active |
| US8992975 | Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia |
May, 2032
(7 years from now) | Active |
| US9468636 | Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia |
May, 2032
(7 years from now) | Active |
| US8658631 | Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia |
May, 2032
(7 years from now) | Active |
| US8980319 | Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans |
Dec, 2030
(6 years from now) | Active |
| US8597681 | Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans |
Dec, 2030
(6 years from now) | Active |
| US8377453 | Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic |
Nov, 2029
(4 years from now) | Active |
| US8372432 | Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic |
Mar, 2029
(4 years from now) | Active |
| US8668929 | Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic |
Mar, 2029
(4 years from now) | Active |
| US8394408 | Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic |
Mar, 2029
(4 years from now) | Active |
| US7976870 | Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract |
Jun, 2027
(2 years from now) | Active |
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
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 Xartemis Xr's patents.
Latest Legal Activities on Xartemis Xr's Patents
Given below is the list of recent legal activities going on the following patents of Xartemis Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 14 Aug, 2023 | US7976870 |
| Maintenance Fee Reminder Mailed Critical | 27 Feb, 2023 | US7976870 |
| Expire Patent Critical | 10 Jan, 2022 | US8597681 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 26 Jul, 2021 | US8597681 (Litigated) |
| Expire Patent Critical | 19 Apr, 2021 | US8394408 |
| Expire Patent Critical | 29 Mar, 2021 | US8377453 |
| Expire Patent Critical | 22 Mar, 2021 | US8372432 |
| Expire Patent Critical | 23 Nov, 2020 | US9468636 |
| Maintenance Fee Reminder Mailed Critical | 02 Nov, 2020 | US8394408 |
| Maintenance Fee Reminder Mailed Critical | 12 Oct, 2020 | US8377453 |
FDA has granted several exclusivities to Xartemis Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xartemis Xr, 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 Xartemis Xr.
Exclusivity Information
Xartemis Xr holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Xartemis Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 11, 2017 |
US patents provide insights into the exclusivity only within the United States, but Xartemis Xr 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 Xartemis Xr's family patents as well as insights into ongoing legal events on those patents.
Xartemis Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xartemis Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 16, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xartemis Xr Generic API suppliers:
Acetaminophen; Oxycodone Hydrochloride is the generic name for the brand Xartemis Xr. 36 different companies have already filed for the generic of Xartemis Xr, with Mikart having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xartemis Xr's generic
About Xartemis Xr
Xartemis Xr is a drug owned by Mallinckrodt Inc. It is used for managing acute pain and treating patients with gastric retentive dosage form. Xartemis Xr uses Acetaminophen; Oxycodone Hydrochloride as an active ingredient. Xartemis Xr was launched by Mallinckrodt Inc in 2014.
Approval Date:
Xartemis Xr was approved by FDA for market use on 11 March, 2014.
Active Ingredient:
Xartemis Xr uses Acetaminophen; Oxycodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Acetaminophen; Oxycodone Hydrochloride ingredient
Treatment:
Xartemis Xr is used for managing acute pain and treating patients with gastric retentive dosage form.
Dosage:
Xartemis Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |