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Last Updated: July 18, 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-six 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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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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION


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

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

Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Sodium nitrite-containing pharmaceutical compositions
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 52129
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191516
Estimated Expiration: ⤷  Sign Up

Patent: 0211077
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 21939
Estimated Expiration: ⤷  Sign Up

Patent: 24426
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 95834
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 95834
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 62007
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 44781
Estimated Expiration: ⤷  Sign Up

Patent: 55250
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 89519
Estimated Expiration: ⤷  Sign Up

Patent: 59297
Estimated Expiration: ⤷  Sign Up

Patent: 12517474
Estimated Expiration: ⤷  Sign Up

Patent: 15199764
Patent: 亜硝酸ナトリウムを含む医薬組成物 (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 95834
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 95834
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 95834
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 95834
Estimated Expiration: ⤷  Sign Up

Patent: 69237
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 43303
Estimated Expiration: ⤷  Sign Up

Patent: 80500
Estimated Expiration: ⤷  Sign Up

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
European Patent Office 3862007 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
Japan 2016153360 チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
Hungary E044781 ⤷  Sign Up
Japan 7166377 ⤷  Sign Up
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) ⤷  Sign Up
Portugal 3569237 ⤷  Sign Up
Slovenia 3569237 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NITHIODOTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3141251 SPC/GB20/075 United Kingdom ⤷  Sign Up PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016
1499331 13C0055 France ⤷  Sign Up PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
2203431 2015/009 Ireland ⤷  Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1259550 08C0052 France ⤷  Sign Up PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
0268956 1999C0030 Belgium ⤷  Sign Up PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2380576 20C1048 France ⤷  Sign Up PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
2563920 CR 2019 00001 Denmark ⤷  Sign Up PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.