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Last Updated: May 26, 2022

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 four patents protecting this drug.

This drug has fifty patent family members in fourteen 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.

Indicators of Generic Entry

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Summary for NITHIODOTE
International Patents:50
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in NITHIODOTE?NITHIODOTE excipients list
DailyMed Link:NITHIODOTE at DailyMed
Drug patent expirations by year for NITHIODOTE
DrugPatentWatch® Estimated 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

NITHIODOTE is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NITHIODOTE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING

Sodium nitrite-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 52129
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0191516
Estimated Expiration: See Plans and Pricing

Patent: 0211077
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

Patent: 62007
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 44781
Estimated Expiration: See Plans and Pricing

Patent: 55250
Estimated Expiration: See Plans and Pricing

Japan

Patent: 89519
Estimated Expiration: See Plans and Pricing

Patent: 59297
Estimated Expiration: See Plans and Pricing

Patent: 12517474
Estimated Expiration: See Plans and Pricing

Patent: 15199764
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

Poland

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 95834
Estimated Expiration: See Plans and Pricing

Patent: 69237
Estimated Expiration: See Plans and Pricing

Spain

Patent: 43303
Estimated Expiration: See Plans and Pricing

Patent: 80500
Estimated Expiration: See Plans and Pricing

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 6852136 See Plans and Pricing
Japan 2017165758 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) See Plans and Pricing
Japan 6598965 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NITHIODOTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 16C0018 France See Plans and Pricing 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
0480717 SPC/GB98/025 United Kingdom See Plans and Pricing PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1874117 2014/032 Ireland See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
McKinsey
Merck
Johnson and Johnson
Baxter

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.