sodium nitrite Drug Patent Profile
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Which patents cover Sodium Nitrite, and when can generic versions of Sodium Nitrite launch?
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 twenty-eight patent family members in fourteen 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.
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Summary for sodium nitrite
International Patents: | 28 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 58 |
Patent Applications: | 1,397 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in sodium nitrite? | sodium nitrite excipients list |
DailyMed Link: | sodium nitrite at DailyMed |
![sodium nitrite drug patent expirations Drug patent expirations by year for sodium nitrite](/p/graph/s/t/sodium_nitrite-patent-expirations.png)
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
sodium nitrite is protected by three US patents.
Patents protecting sodium nitrite
Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
Sodium nitrite-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SODIUM NITRITE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM THIOSULFATE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
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 | ⤷ Sign Up | ⤷ Sign Up | 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
See the table below for patents covering sodium nitrite around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2010093746 | ⤷ Sign Up | |
Croatia | P20191516 | ⤷ Sign Up | |
Poland | 2395834 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium nitrite
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1666481 | 17C1031 | France | ⤷ Sign Up | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
0480717 | SPC/GB98/025 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |