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 | Phase 1 |
| University of Alabama at Birmingham | Early 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Hope Pharms | SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922-001 | Feb 14, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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
Supplementary Protection Certificates for SODIUM NITRITE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 1713823 | 92595 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1912999 | 2014/058 | Ireland | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1758590 | LUC00029 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
