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Generic Nithiodote Availability

Nithiodote is a brand name of sodium nitrite/sodium thiosulfate, approved by the FDA in the following formulation(s):

NITHIODOTE (sodium nitrite; sodium thiosulfate - solution, solution;intravenous, intravenous)

  • Manufacturer: HOPE PHARMS
    Approval date: January 14, 2011
    Strength(s): 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) [RLD]

Has a generic version of Nithiodote been approved?

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

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

  • Sodium thiosulfate-containing pharmaceutical compositions
    Patent 8,496,973
    Issued: July 30, 2013
    Assignee(s): Hope Medical Enterprises, Inc.
    Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.
    Patent expiration dates:
    • March 29, 2031
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      Patent use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
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      Drug substance
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      Drug product
  • Sodium nitrite-containing pharmaceutical compositions
    Patent 8,568,793
    Issued: October 29, 2013
    Assignee(s): Hope Medical Enterprises, Inc.
    Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.
    Patent expiration dates:
    • December 24, 2031
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      Drug substance
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      Drug product

Related Exclusivities

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:
    • January 14, 2018 - ORPHAN DRUG EXCLUSIVITY

More about Nithiodote (sodium nitrite / sodium thiosulfate)

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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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