SODIUM NITRITE - Generic Drug Details
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What are the generic sources for sodium nitrite and what is the scope of freedom to operate?
Sodium nitrite
is the generic ingredient in two branded drugs marketed by Hope Pharms and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium nitrite has twenty-eight patent family members in fourteen countries.
There is one drug master file entry for sodium nitrite. One supplier is listed for this compound.
Summary for SODIUM NITRITE
International Patents: | 28 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 58 |
Patent Applications: | 2,128 |
What excipients (inactive ingredients) are in SODIUM NITRITE? | SODIUM NITRITE excipients list |
DailyMed Link: | SODIUM NITRITE at DailyMed |
Recent Clinical Trials for SODIUM NITRITE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | Early Phase 1 |
University of Alabama at Birmingham | Phase 1 |
National Institutes of Health (NIH) | Phase 1 |
Medical Subject Heading (MeSH) Categories for SODIUM NITRITE
Anatomical Therapeutic Chemical (ATC) Classes for SODIUM NITRITE
US Patents and Regulatory Information for SODIUM NITRITE
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 | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Hope Pharms | SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922-001 | Feb 14, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Subscribe | ⤷ 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 SODIUM NITRITE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1121939 | ⤷ Subscribe | |
European Patent Office | 3569237 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Subscribe |
Croatia | P20211077 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM NITRITE
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
SODIUM NITRITE Market Analysis and Financial Projection Experimental
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