Generic Fentora Availability

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

FENTORA (fentanyl citrate - tablet;buccal, sublingual)

  • Manufacturer: CEPHALON
    Approval date: September 25, 2006
    Strength(s): EQ 0.1MG BASE [AB], EQ 0.2MG BASE [AB], EQ 0.4MG BASE [RLD] [AB], EQ 0.6MG BASE [AB], EQ 0.8MG BASE [AB]

Has a generic version of Fentora been approved?

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

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

  • Sublingual buccal effervescent
    Patent 6,200,604
    Issued: March 13, 2001
    Inventor(s): Pather; Sathasivan Indiran & Khankari; Rajendra K. & Eichman; Jonathan D. & Robinson; Joseph R. & Hontz; John
    Assignee(s): Cima Labs Inc.
    A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administerable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.
    Patent expiration dates:
    • March 26, 2019
      ✓ 
      Patent use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
  • Sublingual buccal effervescent
    Patent 6,974,590
    Issued: December 13, 2005
    Inventor(s): Pather; Sathasivan Indiran & Khankari; Rajendra K. & Eichman; Jonathan D. & Robinson; Joseph R. & Hontz; John
    Assignee(s): Cima Labs Inc.
    A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administerable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.
    Patent expiration dates:
    • March 26, 2019
      ✓ 
      Patent use: MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
  • Generally linear effervescent oral fentanyl dosage form and methods of administering
    Patent 7,862,832
    Issued: January 4, 2011
    Inventor(s): Moe; Derek & Agarwal; Vikas & Habib; Walid
    Assignee(s): Cima Labs, Inc.
    Fentanyl containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than know oral formulation and have advantages in terms of cost and side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
    Patent expiration dates:
    • June 15, 2028
      ✓ 
      Drug product
  • Effervescent oral opiate dosage forms and methods of administering opiates
    Patent 7,862,833
    Issued: January 4, 2011
    Inventor(s): Moe; Derek
    Assignee(s): Cima Labs, Inc.
    Opiate containing dosage forms and methods using same are described. These dosage forms include substantially less opiates by weight than known oral formulations. These dosage forms are intended for oral administration across the oral mucosa.
    Patent expiration dates:
    • June 15, 2028
      ✓ 
      Drug product
  • Generally linear effervescent oral fentanyl dosage form and methods of administering
    Patent 8,092,832
    Issued: January 10, 2012
    Inventor(s): Moe; Derek & Agarwal; Vikas & Habib; Walib
    Assignee(s): Cephalon, Inc.
    Fentanyl containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than know oral formulation and have advantages in terms of cost and side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
    Patent expiration dates:
    • December 30, 2024
      ✓ 
      Drug product
  • Effervescent oral fentanyl dosage form and methods of administering fentanyl
    Patent 8,119,158
    Issued: February 21, 2012
    Inventor(s): Moe; Derek & Agarwal; Vikas & Habib; Walib
    Assignee(s): Cephalon, Inc.
    Fentanyl-containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than known oral formulation and have advantages in terms of reduced cost and reduced side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
    Patent expiration dates:
    • December 30, 2024
      ✓ 
      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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

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