Xartemis Xr Patent Expiration

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

(5 years from now)

Active
US8597681 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Dec, 2030

(5 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.

Given below is the list of recent legal activities going on the following patents of Xartemis Xr.

Activity Date Patent Number
Patent litigations
Expire Patent 14 Aug, 2023 US7976870
Maintenance Fee Reminder Mailed 27 Feb, 2023 US7976870
Expire Patent 10 Jan, 2022 US8597681 (Litigated)
Maintenance Fee Reminder Mailed 26 Jul, 2021 US8597681 (Litigated)
Expire Patent 19 Apr, 2021 US8394408
Expire Patent 29 Mar, 2021 US8377453
Expire Patent 22 Mar, 2021 US8372432
Expire Patent 23 Nov, 2020 US9468636
Maintenance Fee Reminder Mailed 02 Nov, 2020 US8394408
Maintenance Fee Reminder Mailed 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

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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

Xartemis Xr has patent protection in a total of 13 countries. It has a significant patent presence in the US with 67.6% of its patents being US patents. 7 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Xartemis Xr.

Family Patents

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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