Sodium Nitrite is a drug owned by Hope Pharmaceuticals. It is protected by 2 US drug patents filed from 2013 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 24, 2031. Details of Sodium Nitrite's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8568793 | Sodium nitrite-containing pharmaceutical compositions |
Dec, 2031
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9687506 | Sodium nitrite-containing pharmaceutical compositions |
Feb, 2030
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Sodium Nitrite's patents.
Latest Legal Activities on Sodium Nitrite's Patents
Given below is the list of recent legal activities going on the following patents of Sodium Nitrite.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 24 Nov, 2024 | US8568793 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 11 Aug, 2024 | US9687506 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 31 Jan, 2021 | US8568793 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 09 Dec, 2020 | US9687506 |
| Patent Issue Date Used in PTA Calculation | 27 Jun, 2017 | US9687506 |
| Recordation of Patent Grant Mailed | 27 Jun, 2017 | US9687506 |
| Issue Notification Mailed | 07 Jun, 2017 | US9687506 |
| Application Is Considered Ready for Issue | 22 May, 2017 | US9687506 |
| Dispatch to FDC | 22 May, 2017 | US9687506 |
| Issue Fee Payment Received | 19 May, 2017 | US9687506 |
FDA has granted several exclusivities to Sodium Nitrite. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sodium Nitrite, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Sodium Nitrite.
Exclusivity Information
Sodium Nitrite holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Sodium Nitrite's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jan 14, 2018 |
| Orphan Drug Exclusivity(ODE-5) | Jan 14, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Sodium Nitrite is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Sodium Nitrite's family patents as well as insights into
ongoing legal events
on those patents.
Sodium Nitrite's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sodium Nitrite's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 24, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sodium Nitrite Generics:
There are no approved generic versions for Sodium Nitrite as of now.
Alternative Brands for Sodium Nitrite
Sodium Nitrite which is used for treating acute cyanide poisoning through sequential use with sodium thiosulfate., has several other brand drugs in the same treatment category and using the same active ingredient (Sodium Nitrite). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Hope Pharms |
| |||
About Sodium Nitrite
Sodium Nitrite is a drug owned by Hope Pharmaceuticals. It is used for treating acute cyanide poisoning through sequential use with sodium thiosulfate. Sodium Nitrite uses Sodium Nitrite as an active ingredient. Sodium Nitrite was launched by Hope in 2012.
Approval Date:
Sodium Nitrite was approved by FDA for market use on 14 February, 2012.
Active Ingredient:
Sodium Nitrite uses Sodium Nitrite as the active ingredient. Check out other Drugs and Companies using Sodium Nitrite ingredient
Treatment:
Sodium Nitrite is used for treating acute cyanide poisoning through sequential use with sodium thiosulfate.
Dosage:
Sodium Nitrite is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/10ML (30MG/ML) | SOLUTION | Prescription | INTRAVENOUS |