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Generic Dolophine Availability

Dolophine is a brand name of methadone, approved by the FDA in the following formulation(s):

DOLOPHINE HYDROCHLORIDE (methadone hydrochloride - syrup;oral)

  • Manufacturer: WEST-WARD PHARMS INT
    Approved Prior to Jan 1, 1982
    Strength(s): 10MG/30ML

DOLOPHINE HYDROCHLORIDE (methadone hydrochloride - tablet;oral)

  • Manufacturer: WEST-WARD PHARMS INT
    Approved Prior to Jan 1, 1982
    Strength(s): 5MG [RLD] [AA], 10MG [RLD] [AA]

Has a generic version of Dolophine been approved?

Yes. The following products are equivalent to Dolophine:

methadone hydrochloride tablet;oral

  • Manufacturer: AUROLIFE PHARMA LLC
    Approval date: August 31, 2015
    Strength(s): 5MG [AA], 10MG [AA]
  • Manufacturer: ELITE LABS INC
    Approval date: August 2, 2018
    Strength(s): 5MG [AA], 10MG [AA]
  • Manufacturer: EPIC PHARMA LLC
    Approval date: August 18, 2015
    Strength(s): 5MG [AA], 10MG [AA]
  • Manufacturer: SPECGX LLC
    Approval date: April 27, 2004
    Strength(s): 5MG [AA], 10MG [AA]
  • Manufacturer: SUN PHARM INDUSTRIES
    Approval date: March 30, 2018
    Strength(s): 5MG [AA], 10MG [AA]
    Approval date: November 25, 2009
    Strength(s): 10MG [AA]
  • Manufacturer: VISTAPHARM
    Approval date: May 29, 1998
    Strength(s): 10MG [AA]

METHADOSE (methadone hydrochloride tablet;oral)

  • Manufacturer: SPECGX LLC
    Approval date: April 15, 1993
    Strength(s): 5MG [AA], 10MG [AA]

Note: No generic formulation of the following product is available.

  • methadone hydrochloride - syrup;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dolophine. 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 FAQs.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.