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Last Updated: January 19, 2020

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SODIUM NITRITE Drug Profile

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When do Sodium Nitrite patents expire, 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 is one patent protecting this drug.

This drug has fifteen patent family members in eleven 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.

US ANDA Litigation and Generic Entry Outlook for Sodium Nitrite

  Start Trial

A generic version of SODIUM NITRITE was approved as sodium nitrite by HOPE PHARMS on January 19th, 2020.

Summary for SODIUM NITRITE
Drug patent expirations by year for SODIUM NITRITE
Recent Clinical Trials for SODIUM NITRITE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 1
Gladwin, Mark, MDPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 2/Phase 3

See all SODIUM NITRITE clinical trials

Medical Subject Heading (MeSH) Categories for SODIUM NITRITE
Synonyms for SODIUM NITRITE
32863-15-3
56227-20-4
7632-00-0
82497-43-6
82998-40-1
AC1Q1VAY
AC1Q4THG
AKOS024427981
Anti-rust
ANW-36776
Azotyn sodowy
Azotyn sodowy [Polish]
CAS-7632-00-0
Caswell No. 782
CCRIS 559
CHEBI:78870
CHEMBL93268
CTK2H7764
D05865
DB09112
diazoting salts
Diazotizing salts
DSSTox_CID_941
DSSTox_GSID_20941
DSSTox_RID_75879
DTXSID0020941
Dusitan sodny [Czech]
E250
EC 231-555-9
EINECS 231-555-9
EPA Pesticide Chemical Code 076204
Erinitrit
Filmerine
FT-0645124
HMS3652K08
HSDB 757
I14-90844
KB-60553
KS-00000WUJ
KSC377O6J
LPXPTNMVRIOKMN-UHFFFAOYSA-M
M0KG633D4F
MFCD00011118
MolPort-003-926-309
NaNO2
Natrium nitrit
Natrium nitrit [German]
natrium nitrite
NCGC00090737-01
NCGC00090737-02
NCGC00254137-01
NCGC00259704-01
NCI-C02084
Nitrite de sodium
Nitrite de sodium [French]
Nitrite ion standard solution, 0.01 M NO2-, for ion-selective electrodes
Nitrite ion standard solution, 0.1 M NO2-, for ion-selective electrodes
Nitrite, sodium
Nitrito sodico
Nitrito sodico [Spanish]
Nitrous acid, sodium salt
Nitrous acid, sodium salt (1:1)
NNaO2
NSC 77391
RP18285
RTR-037707
S0565
s209
s4074
SC-46815
sodium nitrit
Sodium nitrite (TN)
Sodium nitrite (USP)
Sodium nitrite [UN1500] [Oxidizer]
Sodium nitrite [UN1500] [Oxidizer]
Sodium Nitrite [USAN]
Sodium nitrite [USP]
Sodium nitrite ACS grade
Sodium nitrite solution
Sodium nitrite solution, 40 wt. % in H2O
Sodium nitrite, >=99.99% trace metals basis
Sodium nitrite, 97+%, ACS reagent
Sodium nitrite, 98.5%, for analysis
Sodium nitrite, 99.5%, super free-flowing
Sodium nitrite, 99.999% trace metals basis
Sodium nitrite, 99%, extra pure, contains an anticaking reagent
Sodium nitrite, ACS reagent, >=97.0%
Sodium nitrite, analytical standard
Sodium nitrite, anhydrous, free-flowing, Redi-Dri(TM), ACS reagent, >=97%
Sodium nitrite, AR, >=98%
Sodium nitrite, granular, 99.5%
Sodium nitrite, JIS special grade, >=98.5%
Sodium nitrite, LR, >=98%
Sodium nitrite, p.a., ACS reagent, 99%
Sodium nitrite, puriss. p.a., ACS reagent, >=99.0% (RT)
Sodium nitrite, puriss. p.a., ACS reagent, reag. Ph. Eur., >=99%
Sodium nitrite, puriss., meets analytical specification of Ph. Eur., BP, USP, FCC, E 250, 99-100.5% (calc. to the dried substance)
Sodium nitrite, purum p.a., >=98.0% (RT)
Sodium nitrite, ReagentPlus(R), >=99.0%
Sodium nitrite, SAJ first grade, >=97.0%
Sodium nitrite, Trace metals grade
Sodium nitrite, United States Pharmacopeia (USP) Reference Standard
Sodium nitrite,food grade
sodium-nitrite
sodiumnitrite
SW219150-1
Synfat 1004
Tox21_202155
Tox21_300025
TR-037707
TRA0042859
UN1500
UNII-M0KG633D4F

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 SODIUM NITRITE sodium nitrite SOLUTION;INTRAVENOUS 203922-001 Feb 14, 2012 RX Yes Yes   Start Trial   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

Supplementary Protection Certificates for SODIUM NITRITE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 1590018-6 Sweden   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1758590 LUC00029 Luxembourg   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
1874117 2014/032 Ireland   Start Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2673237 1990016-6 Sweden   Start Trial PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
2203431 15C0013 France   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0145340 99C0005 Belgium   Start Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Dow
Moodys
Harvard Business School
Colorcon

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