Generic Nulibry Availability
Last updated on Feb 8, 2024.
NULIBRY (fosdenopterin hydrobromide - powder;intravenous)
Manufacturer: SENTYNL THERAPS INC
Approval date: February 26, 2021
Strength(s): EQ 9.5MG BASE/VIAL [RLD]
Has a generic version of Nulibry been approved?
No. There is currently no therapeutically equivalent version of Nulibry available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nulibry. 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.
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 expiration dates:
- January 31, 2025✓✓
- January 31, 2025
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- October 27, 2025 - INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102
- February 26, 2026 - NEW CHEMICAL ENTITY
- February 26, 2028 - INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A
More about Nulibry (fosdenopterin)
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- Drug class: miscellaneous metabolic agents
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|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.
|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.
|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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.