Arakoda is a drug owned by 60 Degrees Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2019 to 2023 out of which none have expired yet. Arakoda's patents have been open to challenges since 20 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 02, 2035. Details of Arakoda's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10342791 | Regimens of tafenoquine for prevention of malaria in malaria-naive subjects |
Dec, 2035
(11 years from now) | Active |
| US11744828 | Regimens of tafenoquine for prevention of malaria in malaria-naïve subjects |
Dec, 2035
(11 years from now) | Active |
| US10888558 | Regimens of tafenoquine for prevention of malaria in malaria-naive subjects |
Dec, 2035
(11 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 Arakoda's patents.
Latest Legal Activities on Arakoda's Patents
Given below is the list of recent legal activities going on the following patents of Arakoda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jun, 2024 | US10888558 |
| Email Notification Critical | 05 Sep, 2023 | US11744828 |
| Mail Patent eGrant Notification | 05 Sep, 2023 | US11744828 |
| Recordation of Patent Grant Mailed Critical | 05 Sep, 2023 | US11744828 |
| Patent eGrant Notification | 05 Sep, 2023 | US11744828 |
| Recordation of Patent eGrant | 05 Sep, 2023 | US11744828 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Sep, 2023 | US11744828 |
| Email Notification Critical | 17 Aug, 2023 | US11744828 |
| Electronic Review Critical | 17 Aug, 2023 | US11744828 |
| Issue Notification Mailed Critical | 16 Aug, 2023 | US11744828 |
FDA has granted several exclusivities to Arakoda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arakoda, 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 Arakoda.
Exclusivity Information
Arakoda holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Arakoda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 08, 2021 |
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2023 |
US patents provide insights into the exclusivity only within the United States, but Arakoda 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 Arakoda's family patents as well as insights into ongoing legal events on those patents.
Arakoda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Arakoda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 02, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arakoda Generics:
There are no approved generic versions for Arakoda as of now.
About Arakoda
Arakoda is a drug owned by 60 Degrees Pharmaceuticals Inc. It is used for preventing malaria in adults through a three-phase dosing regimen. Arakoda uses Tafenoquine Succinate as an active ingredient. Arakoda was launched by 60 Degrees Pharms in 2018.
Approval Date:
Arakoda was approved by FDA for market use on 08 August, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Arakoda is 08 August, 2018, its NCE-1 date is estimated to be 20 July, 2022.
Active Ingredient:
Arakoda uses Tafenoquine Succinate as the active ingredient. Check out other Drugs and Companies using Tafenoquine Succinate ingredient
Treatment:
Arakoda is used for preventing malaria in adults through a three-phase dosing regimen.
Dosage:
Arakoda is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |