SODIUM NITRITE Drug Patent Profile
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Which patents cover Sodium Nitrite, and what generic alternatives are available?
Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has thirty patent family members in fifteen countries.
The generic ingredient in SODIUM NITRITE is sodium nitrite. 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 profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Nitrite
A generic version of SODIUM NITRITE was approved as sodium nitrite by HOPE PHARMS on February 14th, 2012.
US Patents and Regulatory Information for SODIUM NITRITE
SODIUM NITRITE is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SODIUM NITRITE is ⤷ Start Trial.
This potential generic entry date is based on patent 9,687,506.
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 | SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922-001 | Feb 14, 2012 | RX | Yes | Yes | 9,687,506 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Hope Pharms | SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922-001 | Feb 14, 2012 | RX | Yes | Yes | 8,568,793 | ⤷ Start Trial | Y | Y | ⤷ Start 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 SODIUM NITRITE
When does loss-of-exclusivity occur for SODIUM NITRITE?
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: ⤷ Start Trial
Canada
Patent: 52129
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0191516
Estimated Expiration: ⤷ Start Trial
Patent: 0211077
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 24426
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 95834
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 95834
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial
Patent: 62007
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 44781
Estimated Expiration: ⤷ Start Trial
Patent: 55250
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 89519
Estimated Expiration: ⤷ Start Trial
Patent: 59297
Estimated Expiration: ⤷ Start Trial
Patent: 12517474
Patent: 亜硝酸ナトリウムを含む医薬組成物
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
Lithuania
Patent: 95834
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 95834
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 95834
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 95834
Estimated Expiration: ⤷ Start Trial
Patent: 69237
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 43303
Estimated Expiration: ⤷ Start Trial
Patent: 80500
Estimated Expiration: ⤷ Start 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 SODIUM NITRITE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Lithuania | 2395834 | ⤷ Start Trial | |
| Slovenia | 2395834 | ⤷ Start Trial | |
| Hungary | E055250 | ⤷ Start Trial | |
| European Patent Office | 3862007 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Start Trial |
| Japan | 2012517474 | 亜硝酸ナトリウムを含む医薬組成物 | ⤷ Start Trial |
| Hungary | E044781 | ⤷ Start Trial | |
| European Patent Office | 2395834 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM NITRITE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1856135 | SPC/GB20/016 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Start Trial | 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 |
| 3141251 | 301099 | Netherlands | ⤷ Start Trial | 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, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 2563920 | CR 2019 00001 | Denmark | ⤷ Start Trial | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 0579826 | 02C0041 | France | ⤷ Start Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 2340828 | LUC00195 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| 1856135 | CA 2020 00018 | Denmark | ⤷ Start Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Investment Scenario and Fundamentals Analysis for Sodium Nitrite
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