Generic Abstral Availability

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

ABSTRAL (fentanyl citrate - tablet;sublingual)

  • Manufacturer: GALENA BIOPHARMA
    Approval date: January 7, 2011
    Strength(s): EQ 0.1MG BASE, EQ 0.2MG BASE, EQ 0.3MG BASE, EQ 0.4MG BASE [RLD], EQ 0.6MG BASE, EQ 0.8MG BASE

Has a generic version of Abstral been approved?

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

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

  • Fentanyl composition for the treatment of acute pain
    Patent 6,759,059
    Issued: July 6, 2004
    Inventor(s): Anders; Pettersson & Christer; Nystrom & Hans; Lennernas & Bo; Lennernas & Thomas; Hedner
    Assignee(s): Diabact AB
    A pharmaceutical composition for the treatment of acute pain by sublingual administration is described. The composition comprises an essentially water-free, ordered mixture of fentanyl or a pharmaceutically acceptable salt thereof in the form of microparticles which are adhered to the surface of carrier particles which are substantially larger than the particles of fentanyl, and are essentially water-soluble. In a preferred embodiment, the composition also contains a bioadhesion and/or mucoadhesion promoting agent. The invention also relates to the preparation of the composition, and to the use of the composition for the treatment of acute pain.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
      ✓ 
      Drug product
  • Pharmaceutical composition for the treatment of acute disorders
    Patent 6,761,910
    Issued: July 13, 2004
    Inventor(s): Anders; Pettersson & Christer; Nystrom
    Assignee(s): Diabact AB
    A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
      ✓ 
      Drug product
  • Pharmaceutical composition for the treatment of acute disorders
    Patent 7,910,132
    Issued: March 22, 2011
    Inventor(s): Pettersson; Anders & Nystrom; Christer
    Assignee(s): Orexo AB
    A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
      ✓ 
      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.
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