Pill Identifier App

Generic Opana ER Availability

See also: Generic Opana

Opana ER is a brand name of oxymorphone, approved by the FDA in the following formulation(s):

OPANA ER (oxymorphone hydrochloride - tablet, extended release;oral)

  • Manufacturer: ENDO PHARMS
    Approval date: December 9, 2011
    Strength(s): 5MG, 7.5MG, 10MG, 15MG, 20MG, 30MG, 40MG [RLD]

Has a generic version of Opana ER been approved?

No. There is currently no therapeutically equivalent version of Opana ER available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Opana ER. 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.

  • Controlled release formulation (albuterol)
    Patent 5,662,933
    Issued: September 2, 1997
    Inventor(s): Baichwal; Anand & McCall; Troy W.
    Assignee(s): Edward Mendell Co., Inc.
    A sustained release pharmaceutical formulation and methods of making and using the same are provided. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.
    Patent expiration dates:
    • September 9, 2013
      ✓ 
      Drug product
  • Controlled release formulation (albuterol)
    Patent 5,958,456
    Issued: September 28, 1999
    Inventor(s): Baichwal; Anand & McCall; Troy W.
    Assignee(s): Edward Mendell Co., Inc.
    A sustained release pharmaceutical formulation and methods of making and using the same are provided. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.
    Patent expiration dates:
    • September 9, 2013
      ✓ 
      Drug product
  • Sustained release formulations of oxymorphone
    Patent 7,276,250
    Issued: October 2, 2007
    Inventor(s): Baichwal; Anand R. & Kao; Huai-Hung & McCall; Troy W.
    Assignee(s): Penwest Pharmaceuticals Company
    Sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; methods for making the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; and methods for using the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof to treat patients suffering from pain are provided.
    Patent expiration dates:
    • February 4, 2023
      ✓ 
      Patent use: RELIEF OF MODERATE TO SEVERE PAIN
      ✓ 
      Drug product
  • Method for making analgesics
    Patent 7,851,482
    Issued: December 14, 2010
    Inventor(s): Dung; Jen-Sen & Keskeny; Erno M. & Mencel; James J.
    Assignee(s): Johnson Matthey Public Limited Compnay
    Improved analgesic oxymorphone hydrochloride contains less than 10 ppm of alpha, beta unsaturated ketones and pharmaceutical preparations comprising such oxymorphone hydrochloride. The oxymorphone hydrochloride is produced by reducing a starting material oxymorphone hydrochloride using gaseous hydrogen and under specified acidity, solvent system and temperature conditions. A specific polymorph of oxymorphone hydrochloride may be obtained by hydration.
    Patent expiration dates:
    • July 10, 2029
      ✓ 
      Drug substance
  • Abuse-proofed dosage form
    Patent 8,075,872
    Issued: December 13, 2011
    Inventor(s): Arkenau-Maric; Elisabeth & Bartholomäus; Johannes & Kugelmann; Heinrich
    Assignee(s): Gruenenthal GmbH
    The invention relates to a dosage form that is thermoshaped without being extruded and that is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse and optionally physiologically acceptable adjuvants. The invention also relates to a corresponding method for producing said dosage form.
    Patent expiration dates:
    • November 20, 2023
      ✓ 
      Drug product
  • Abuse-proofed dosage form
    Patent 8,114,383
    Issued: February 14, 2012
    Inventor(s): Bartholomäus; Johannes & Kugelmann; Heinrich & Arkenau-Marić; Elisabeth
    Assignee(s): Gruenenthal GmbH
    The present invention relates to an abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.
    Patent expiration dates:
    • August 8, 2024
      ✓ 
      Drug product
  • Abuse-proof dosage form
    Patent 8,192,722
    Issued: June 5, 2012
    Inventor(s): Arkenau-Maric; Elisabeth & Bartholomaus; Johannes & Kugelmann; Heinrich
    Assignee(s): Grunenthal GmbH
    The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form.
    Patent expiration dates:
    • September 15, 2025
      ✓ 
      Drug product
  • Abuse-proofed dosage form
    Patent 8,309,060
    Issued: November 13, 2012
    Inventor(s): Bartholomaus; Johannes & Kugelmann; Heinrich & Arkenau-Marić; Elisabeth
    Assignee(s): Grunenthal GmbH
    An abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.
    Patent expiration dates:
    • November 20, 2023
      ✓ 
      Drug product
  • Oxymorphone controlled release formulations
    Patent 8,309,122
    Issued: November 13, 2012
    Inventor(s): Kao; Huai-Hung & Baichwal; Anand R. & McCall; Troy & Lee; David
    Assignee(s): Endo Pharmaceuticals Inc.
    The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.
    Patent expiration dates:
    • February 4, 2023
      ✓ 
      Drug product
  • Oxymorphone controlled release formulations
    Patent 8,329,216
    Issued: December 11, 2012
    Inventor(s): Kao; Haui-Hung & Baichwal; Anand R. & McCall; Troy & Lee; David
    Assignee(s): Endo Pharmaceuticals Inc.
    The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.
    Patent expiration dates:
    • February 4, 2023
      ✓ 
      Drug 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
(web5)