Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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 four 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:4
Generic Entry Opportunity 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-USE (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:  Start TrialPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Patent:  Start TrialPatent Expiration:Dec 24, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING

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