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Federal Trade Commission
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Covington
Teva
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Generated: February 20, 2019

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NITHIODOTE Drug Profile

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When do Nithiodote patents expire, and when can generic versions of Nithiodote launch?

Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-three patent family members in eight countries.

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 NITHIODOTE
International Patents:23
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:NITHIODOTE at DailyMed
Drug patent expirations by year for NITHIODOTE
Generic Entry Opportunity Date for NITHIODOTE
Generic Entry Date for NITHIODOTE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for NITHIODOTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for NITHIODOTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0018 France ➤ Try a Free Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
C0108 Belgium ➤ Try a Free Trial PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
C/GB97/078 United Kingdom ➤ Try a Free Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKesson
Harvard Business School
Johnson and Johnson
McKinsey
Merck
Accenture
Chubb
Queensland Health

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