Nithiodote is a drug owned by Hope Pharmaceuticals. It is protected by 8 US drug patents filed from 2013 to 2025 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 Nithiodote'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
(6 years from now) | Active |
| US8496973 | Sodium thiosulfate-containing pharmaceutical compositions |
Mar, 2031
(5 years from now) | Active |
| US9585912 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(4 years from now) | Active |
| US9345724 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(4 years from now) | Active |
| US11753301 | Sodium thiosulfate-containing pharmaceutical compositions |
Feb, 2030
(4 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). | |||
| US10479686 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(4 years from now) | Active |
| US9687506 | Sodium nitrite-containing pharmaceutical compositions |
Feb, 2030
(4 years from now) | Active |
| US12304813 | Sodium thiosulfate-containing pharmaceutical compositions |
Feb, 2030
(4 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 Nithiodote's patents.
Latest Legal Activities on Nithiodote's Patents
Given below is the list of recent legal activities going on the following patents of Nithiodote.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 22 Nov, 2023 | US9345724 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11753301 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11753301 |
| Recordation of Patent Grant Mailed
Critical | 12 Sep, 2023 | US11753301 |
| Patent eGrant Notification | 12 Sep, 2023 | US11753301 |
| Patent Issue Date Used in PTA Calculation
Critical | 12 Sep, 2023 | US11753301 |
| Email Notification
Critical | 12 Sep, 2023 | US11753301 |
| Email Notification
Critical | 24 Aug, 2023 | US11753301 |
| Issue Notification Mailed
Critical | 23 Aug, 2023 | US11753301 |
| Application Is Considered Ready for Issue
Critical | 02 Aug, 2023 | US11753301 |
FDA has granted several exclusivities to Nithiodote. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nithiodote, 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
Nithiodote.
Exclusivity Information
Nithiodote holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Nithiodote'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 |
Several oppositions have been filed on Nithiodote's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Nithiodote's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Nithiodote patents.
Nithiodote's Oppositions Filed in EPO
Nithiodote has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 30, 2018, by Dr. Franz Köhler Chemie Gmbh. This opposition was filed on patent number EP10797770A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10797770A | Jul, 2018 | Shimamura, Naomi | Patent maintained as amended |
| EP10797770A | Jul, 2018 | Dr. Franz Köhler Chemie GmbH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Nithiodote 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 Nithiodote's family patents as well as insights into
ongoing legal events
on those patents.
Nithiodote's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nithiodote'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)
Nithiodote Generics:
There are no approved generic versions for Nithiodote as of now.
Alternative Brands for Nithiodote
Nithiodote which is used for treating acute cyanide poisoning., has several other brand drugs in the same treatment category . 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 Nithiodote
Nithiodote is a drug owned by Hope Pharmaceuticals. It is used for treating acute cyanide poisoning. Nithiodote uses Sodium Nitrite; Sodium Thiosulfate as an active ingredient. Nithiodote was launched by Hope Pharms in 2011.
Approval Date:
Nithiodote was approved by FDA for market use on 14 January, 2011.
Active Ingredient:
Nithiodote uses Sodium Nitrite; Sodium Thiosulfate as the active ingredient. Check out other Drugs and Companies using Sodium Nitrite; Sodium Thiosulfate ingredient
Treatment:
Nithiodote is used for treating acute cyanide poisoning.
Dosage:
Nithiodote is available in solution, solution form for intravenous, intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) | SOLUTION, SOLUTION | Prescription | INTRAVENOUS, INTRAVENOUS |