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 six patents protecting this drug.
This drug has fifty-two 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.
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
Summary for NITHIODOTE
International Patents: | 52 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Patent Applications: | 4 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NITHIODOTE |
What excipients (inactive ingredients) are in NITHIODOTE? | NITHIODOTE excipients list |
DailyMed Link: | NITHIODOTE at DailyMed |

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.
Anatomical Therapeutic Chemical (ATC) Classes for NITHIODOTE
US Patents and Regulatory Information for NITHIODOTE
NITHIODOTE is protected by seven 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
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 | 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 | ⤷ 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
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 |
---|---|---|---|
Canada | 2752129 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
Spain | 2655883 | ⤷ Try a Trial | |
Japan | 5905387 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Japan | 7166377 | ⤷ Try a Trial | |
Spain | 2743303 | ⤷ 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 |
---|---|---|---|---|
2822954 | 1890030-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
1948158 | 93075 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL ET 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-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
0579826 | 02C0041 | France | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
0480717 | SPC/GB98/025 | United Kingdom | ⤷ Try a Trial | 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 |
2666774 | CA 2020 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |