Generic Fentora Availability
Last updated on Aug 7, 2024.
Fentora is a brand name of fentanyl, approved by the FDA in the following formulation(s):
FENTORA (fentanyl citrate - tablet;buccal, sublingual)
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Manufacturer: CEPHALON
Approval date: September 25, 2006
Strength(s): EQ 0.1MG BASE [RLD], EQ 0.2MG BASE [RLD], EQ 0.4MG BASE [RLD], EQ 0.6MG BASE [RLD], EQ 0.8MG BASE [RLD] -
Manufacturer: CEPHALON
Approval date: March 2, 2007
Strength(s): EQ 0.3MG BASE (discontinued) [RLD]
Has a generic version of Fentora been approved?
An Authorized Generic version of Fentora has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Fentanyl Citrate BUCCAL; SUBLINGUAL TABLET 100 ug
Mayne Pharma
NDC Code: 518620634 - Fentanyl Citrate BUCCAL; SUBLINGUAL TABLET 200 ug
Mayne Pharma
NDC Code: 518620635 - Fentanyl Citrate BUCCAL; SUBLINGUAL TABLET 400 ug
Mayne Pharma
NDC Code: 518620636 - Fentanyl Citrate BUCCAL; SUBLINGUAL TABLET 600 ug
Mayne Pharma
NDC Code: 518620637 - Fentanyl Citrate BUCCAL; SUBLINGUAL TABLET 800 ug
Mayne Pharma
NDC Code: 518620638
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: 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.
-
Patent 7,862,832
Patent expiration dates:
- June 15, 2028✓
- June 15, 2028
-
Patent 7,862,833
Patent expiration dates:
- June 15, 2028✓
- June 15, 2028
-
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✓
- December 30, 2024
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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✓
- December 30, 2024
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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.