Generic Opana ER Availability
Last updated on Apr 10, 2025.
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 OPERATIONS
Approval date: June 22, 2006
Strength(s): 5MG (discontinued) [RLD], 10MG (discontinued) [RLD], 20MG (discontinued) [RLD], 40MG (discontinued) [RLD] -
Manufacturer: ENDO OPERATIONS
Approval date: February 29, 2008
Strength(s): 7.5MG (discontinued) [RLD], 15MG (discontinued) [RLD], 30MG (discontinued) [RLD] -
Manufacturer: ENDO PHARMS
Approval date: December 9, 2011
Strength(s): 5MG (discontinued) [RLD], 7.5MG (discontinued) [RLD], 10MG (discontinued) [RLD], 15MG (discontinued) [RLD], 20MG (discontinued) [RLD], 30MG (discontinued) [RLD], 40MG (discontinued) [RLD]
All of the above formulations have been discontinued.
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: 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.
-
Method for making analgesics
Patent 7,851,482
Issued: December 14, 2010
Inventor(s): Dung; Jen-Sen et al.
Assignee(s): Johnson Matthey Public Limited Compnay (London, GB)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✓
- July 10, 2029
-
Abuse-proof dosage form
Patent 8,192,722
Issued: June 5, 2012
Inventor(s): Arkenau-Maric Elisabeth & Bartholomaus Johannes & Kugelmann Heinrich
Assignee(s): Grunenthal GmbHThe 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✓
- September 15, 2025
-
Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent 8,808,737
Issued: August 19, 2014
Inventor(s): Ahdieh Harry
Assignee(s): Endo Pharmaceuticals Inc.The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment.
Patent expiration dates:
- June 21, 2027✓
- June 21, 2027✓
- June 21, 2027
-
Process for preparing morphinan-6-one products with low levels of α,β-unsaturated ketone compounds
Patent 8,871,779
Issued: October 28, 2014
Inventor(s): Buehler Henry J. & Dummitt William E. & Mannino Anthony & Aubuchon Dennis C. & Gu Hong
Assignee(s): Mallinckrodt LLCThe present invention generally relates to processes for preparing highly pure morphinan-6-one products. The processes involve reducing the concentration of α,β-unsaturated ketone compounds present as impurities in morphinan 6 one products or reaction mixtures including morphinan 6 one compounds by treatment with a sulfur-containing compound. (A)
Patent expiration dates:
- November 22, 2029✓
- November 22, 2029
More about Opana ER (oxymorphone)
- Opana ER consumer information
- Check interactions
- Compare alternatives
- Reviews (84)
- Drug images
- Latest FDA alerts (3)
- Side effects
- Dosage information
- During pregnancy
- Drug class: Opioids (narcotic analgesics)
- Breastfeeding
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
