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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Questions you can ask:
- What is the 5 year forecast for NITHIODOTE?
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- What is Average Wholesale Price for NITHIODOTE?
Summary for NITHIODOTE
International Patents: | 56 |
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 ⤷ Subscribe.
This potential generic entry date is based on patent 8,568,793.
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 | 8,496,973 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | 9,585,912 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | 9,687,506 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | 8,568,793 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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: ⤷ Subscribe
Canada
Patent: 52129
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0191516
Estimated Expiration: ⤷ Subscribe
Patent: 0211077
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 21939
Estimated Expiration: ⤷ Subscribe
Patent: 24426
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 95834
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 95834
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Patent: 62007
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 44781
Estimated Expiration: ⤷ Subscribe
Patent: 55250
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 89519
Estimated Expiration: ⤷ Subscribe
Patent: 59297
Estimated Expiration: ⤷ Subscribe
Patent: 12517474
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Lithuania
Patent: 95834
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 95834
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 95834
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 95834
Estimated Expiration: ⤷ Subscribe
Patent: 69237
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 43303
Estimated Expiration: ⤷ Subscribe
Patent: 80500
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Portugal | 2395834 | ⤷ Subscribe | |
Slovenia | 3569237 | ⤷ Subscribe | |
Japan | 2019048852 | 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) | ⤷ Subscribe |
Poland | 2451435 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NITHIODOTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0290047 | SPC/GB97/078 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
2203431 | 15C0013 | France | ⤷ Subscribe | PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119 |
0480717 | 98C0022 | France | ⤷ Subscribe | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
NITHIODOTE Market Analysis and Financial Projection Experimental
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