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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 201444


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NDA 201444 describes NITHIODOTE, which is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NITHIODOTE profile page.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite; sodium thiosulfate profile page.
Summary for 201444
Tradename:NITHIODOTE
Applicant:Hope Pharms
Ingredient:sodium nitrite; sodium thiosulfate
Patents:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 201444
Generic Entry Date for 201444*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 201444
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444 NDA Hope Pharmaceuticals 60267-812 60267-812-00 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUSStrength300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)
Approval Date:Jan 14, 2011TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 7, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
Patent:⤷  Sign UpPatent Expiration:Feb 10, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING
Patent:⤷  Sign UpPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.