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Last Updated: March 28, 2024

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NITHIODOTE Drug Patent Profile


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Which patents cover Nithiodote, and when can generic versions of Nithiodote launch?

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

This drug has fifty-four patent family members in fifteen 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.

DrugPatentWatch® Generic Entry Outlook for Nithiodote

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 24, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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  Try a Trial

Drug patent expirations by year for NITHIODOTE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

NITHIODOTE is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NITHIODOTE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NITHIODOTE

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING

Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION

Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM NITRITE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM THIOSULFATE FOR THE TREATMENT OF ACUTE CYANIDE POISONING

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

International Patents for NITHIODOTE

When does loss-of-exclusivity occur for NITHIODOTE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10213743
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 52129
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0191516
Estimated Expiration: ⤷  Try a Trial

Patent: 0211077
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24426
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

Patent: 62007
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 44781
Estimated Expiration: ⤷  Try a Trial

Patent: 55250
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 89519
Estimated Expiration: ⤷  Try a Trial

Patent: 59297
Estimated Expiration: ⤷  Try a Trial

Patent: 12517474
Estimated Expiration: ⤷  Try a Trial

Patent: 15199764
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 95834
Estimated Expiration: ⤷  Try a Trial

Patent: 69237
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 43303
Estimated Expiration: ⤷  Try a Trial

Patent: 80500
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NITHIODOTE around the world.

Country Patent Number Title Estimated Expiration
Japan 7408753 ⤷  Try a Trial
Japan 6438071 ⤷  Try a Trial
Japan 6852136 ⤷  Try a Trial
Japan 2020011992 チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Lithuania 3569237 ⤷  Try a Trial
Japan 5905387 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NITHIODOTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 2015/009 Ireland ⤷  Try a Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1874117 2014/032 Ireland ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2822954 2018/031 Ireland ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1912999 2014/058 Ireland ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1259550 08C0052 France ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
2380576 SPC/GB20/050 United Kingdom ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.