Generic Xartemis XR Availability
Last updated on May 7, 2025.
Xartemis XR is a brand name of acetaminophen/oxycodone, approved by the FDA in the following formulation(s):
XARTEMIS XR (acetaminophen; oxycodone hydrochloride - tablet, extended release;oral)
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Manufacturer: MALLINCKRODT INC
Approval date: March 11, 2014
Strength(s): 325MG;7.5MG (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xartemis XR. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Patent 7,976,870
Issued: July 12, 2011
Inventor(s): Berner; Bret et al.
Assignee(s): Depomed, Inc. (Menlo Park, CA)Controlled release oral dosage forms are provided for the continuous, sustained administration of a pharmacologically active agent to the upper gastrointestinal tract of a patient in whom the fed mode as been induced. The majority of the agent is delivered, on an extended release basis, to the stomach, duodenum and upper regions of the small intestine, with drug delivery in the lower gastrointestinal tract and colon substantially restricted. The dosage form comprises a matrix of a biocompatible, hydrophilic, erodible polymer with an active agent incorporated therein, wherein the polymer is one that both swells in the presence of water and gradually erodes over a time period of hours, with swelling and erosion commencing upon contact with gastric fluid, and drug release rate primarily controlled by erosion rate.
Patent expiration dates:
- June 1, 2027✓
- June 1, 2027
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Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent 8,372,432
Issued: February 12, 2013
Inventor(s): Han Chien-Hsuan & Hou Sui Yuen Eddie & Reid Monica L.
Assignee(s): Depomed, Inc.Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.
Patent expiration dates:
- March 11, 2029✓✓
- March 11, 2029
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Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent 8,377,453
Issued: February 19, 2013
Inventor(s): Han Chien-Hsuan & Hou Sui Yuen Eddie & Reid Monica L.
Assignee(s): Depomed, Inc.Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.
Patent expiration dates:
- November 19, 2029✓✓
- November 19, 2029
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Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent 8,394,408
Issued: March 12, 2013
Inventor(s): Han Chien-Hsuan & Hou Sui Yuen Eddie & Reid Monica L.
Assignee(s): Depomed, Inc.Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.
Patent expiration dates:
- March 11, 2029✓
- March 11, 2029
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Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Patent 8,597,681
Issued: December 3, 2013
Inventor(s): Park Jae Han & Eisenhauer Tiffani & Dhanarajan Anish & Gupta Vishal K. & Overholt Stephen
Assignee(s): Mallinckrodt LLCMethods for producing stabilized solid dosage form pharmaceutical compositions are provided. In particular, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided.
Patent expiration dates:
- December 21, 2030✓
- December 21, 2030
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Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent 8,658,631
Issued: February 25, 2014
Inventor(s): Devarakonda Krishna & Guiliani Michael J & Gupta Vishal K & Heasley Ralph A & Shelby Susan
Assignee(s): Mallinckrodt LLCThe present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.
Patent expiration dates:
- May 16, 2032✓
- May 16, 2032
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Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent 8,668,929
Issued: March 11, 2014
Inventor(s): Han Chien-Hsuan & Hou Sui Yuen Eddie & Reid Monica L.
Assignee(s): Depomed, Inc.Compositions and methods for the treatment of pain in a mammal are described. More specifically, a dosage form designed for release of acetaminophen and an opioid is described, wherein the dosage form provides delivery of the drugs to the upper gastrointestinal tract (“GI”) of a mammal for an extended period of time.
Patent expiration dates:
- March 11, 2029✓
- March 11, 2029
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Gastric retentive extended release pharmaceutical compositions
Patent 8,741,885
Issued: June 3, 2014
Inventor(s): Devarakonda Krishna & Guiliani Michael J & Gupta Vishal K & Heasley Ralph A & Shelby Susan
Assignee(s): Mallinckrodt LLCThe present disclosure provides extended release pharmaceutical compositions comprising an opioid and an additional active pharmaceutical ingredient, wherein the composition exhibits gastric retentive properties which are achieved by a combination of a physical property of the composition and release of the opioid, wherein upon administration to a subject, the composition has at least one pharmacokinetic parameter that differs by less than about 30% when the subject is in a fasted state as compared to a fed state.
Patent expiration dates:
- May 16, 2032✓✓
- May 16, 2032
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Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Patent 8,980,319
Issued: March 17, 2015
Inventor(s): Park Jae Han & Eisenhauer Tiffani & Dhanarajan Anish & Gupta Vishal & Overholt Stephen
Assignee(s): Mallinckrodt LLCMethods for producing stabilized solid dosage form pharmaceutical compositions are provided. In particular, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided.
Patent expiration dates:
- December 21, 2030✓
- December 21, 2030
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Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent 8,992,975
Issued: March 31, 2015
Inventor(s): Devarakonda Krishna R. & Giuliani Michael J. & Gupta Vishal K. & Heasley Ralph A. & Shelby Susan
Assignee(s): Mallinckrodt LLCThe present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.
Patent expiration dates:
- May 16, 2032✓
- May 16, 2032
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Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
Patent 9,050,335
Issued: June 9, 2015
Inventor(s): Devarakonda Krishna & Giuliani Michael J. & Gupta Vishal K. & Heasley Ralph A. & Shelby Susan
Assignee(s): MALLINCKRODT LLCThe present disclosure provides extended release pharmaceutical compositions comprising oxycodone and acetaminophen that produce a quick initial onset of analgesia, yet, maintain analgesia for about 12 hours after administration of the composition to a subject in need thereof. The pharmaceutical compositions disclosed herein also reduce the levels of acetaminophen in a subject's blood near the end of the dosing interval because the acetaminophen released by the pharmaceutical composition is being eliminated by a subjects body faster than it is being absorbed.
Patent expiration dates:
- May 16, 2032✓
- May 16, 2032
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Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent 9,468,636
Issued: October 18, 2016
Inventor(s): Devarakonda Krishna R. & Giuliani Michael J. & Gupta Vishal K. & Heasley Ralph A. & Shelby Susan
Assignee(s): MALLINCKRODT LLCThe present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.
Patent expiration dates:
- May 16, 2032✓
- May 16, 2032
More about Xartemis XR (acetaminophen / oxycodone)
- Xartemis XR consumer information
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- Reviews (5)
- Drug images
- Latest FDA alerts (5)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: narcotic analgesic combinations
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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