Skip to Content

Generic Xartemis XR Availability

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)

Has a generic version of Xartemis XR been approved?

No. There is currently no therapeutically equivalent version of Xartemis XR available in the United States.

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: About generic drugs.

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.

  • Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
    Patent 6,488,962
    Issued: December 3, 2002
    Inventor(s): Bret; Berner & Jenny; Louie-Helm
    Assignee(s): DepoMed, Inc.
    The retention of oral drug dosage forms in the stomach is improved by using swellable dosage forms that are shaped in a manner that will prevent them from inadvertently passing through the pylorus as a result of being in a particular orientation. The planar projection of the shape is one that has two orthogonal axes of different lengths, the longer being short enough to permit easy swallowing prior to swelling while the shorter is long enough within one-half hour of swelling to prevent passage through the pylorus.
    Patent expiration dates:
    • June 20, 2020
      ✓ 
      Drug product
  • 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 & Louie-Helm; Jenny & Shell; John W.
    Assignee(s): Depomed, Inc.
    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
      ✓ 
      Patent use: METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
  • 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
    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
      ✓ 
      Patent use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
      ✓ 
      Drug product
  • 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
    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
      ✓ 
      Patent use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
      ✓ 
      Drug product
  • 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
    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
      ✓ 
      Drug product
  • Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
    Patent 8,597,681
    Issued: December 3, 2013
    Assignee(s): Mallinckrodt LLC
    Methods 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
      ✓ 
      Drug product
  • Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
    Patent 8,658,631
    Issued: February 25, 2014
    Assignee(s): Mallinckrodt LLC
    The 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
      ✓ 
      Drug product
  • 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
    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
      ✓ 
      Patent use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
  • Gastric retentive extended release pharmaceutical compositions
    Patent 8,741,885
    Issued: June 3, 2014
    Assignee(s): Mallinckrodt LLC
    The 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
      ✓ 
      Patent use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
      ✓ 
      Drug product
  • Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
    Patent 8,980,319
    Issued: March 17, 2015
    Assignee(s): Mallinckrodt LLC
    Methods 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
      ✓ 
      Drug product
  • Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
    Patent 8,992,975
    Issued: March 31, 2015
    Assignee(s): Mallinckrodt LLC
    The 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
      ✓ 
      Drug product
  • 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
    Assignee(s): MALLINCKRODT LLC
    The 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
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • March 11, 2017 - NEW PRODUCT

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
Hide