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-seven 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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Questions you can ask:
- What is the 5 year forecast for NITHIODOTE?
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Summary for NITHIODOTE
International Patents: | 57 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Patent Applications: | 2 |
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.
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 for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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: ⤷ Try for Free
Canada
Patent: 52129
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0191516
Estimated Expiration: ⤷ Try for Free
Patent: 0211077
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 21939
Estimated Expiration: ⤷ Try for Free
Patent: 24426
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 95834
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 95834
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 62007
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 44781
Estimated Expiration: ⤷ Try for Free
Patent: 55250
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 89519
Estimated Expiration: ⤷ Try for Free
Patent: 59297
Estimated Expiration: ⤷ Try for Free
Patent: 12517474
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Lithuania
Patent: 95834
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 95834
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 95834
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 95834
Estimated Expiration: ⤷ Try for Free
Patent: 69237
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 43303
Estimated Expiration: ⤷ Try for Free
Patent: 80500
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Spain | 2655883 | ⤷ Try for Free | |
Poland | 2451435 | ⤷ Try for Free | |
Poland | 2395834 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NITHIODOTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0806968 | SPC/GB07/011 | United Kingdom | ⤷ Try for Free | 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 |
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
2932970 | 18C1043 | France | ⤷ Try for Free | PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Nithiodote
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