Ojemda is a drug owned by Day One Biopharmaceuticals Inc. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Ojemda's patents will be open to challenges from 23 April, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 23, 2035. Details of Ojemda'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. | |||
| US8293752 | Compounds useful as Raf kinase inhibitors |
Aug, 2031
(6 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). | |||
| US10426782 | Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation |
Jun, 2035
(10 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 Ojemda's patents.
Latest Legal Activities on Ojemda's Patents
Given below is the list of recent legal activities going on the following patents of Ojemda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Application under 35 USC 156 Filed | 18 Jun, 2024 | US8293752 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Mar, 2024 | US8293752 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 Nov, 2023 | US8293752 |
| Email Notification Critical | 15 Nov, 2023 | US8293752 |
| Electronic Review Critical | 01 Jun, 2023 | US8293752 |
| Mail Pre-Exam Notice | 01 Jun, 2023 | US8293752 |
| Email Notification Critical | 01 Jun, 2023 | US8293752 |
| Electronic Review Critical | 22 May, 2023 | US8293752 |
| Email Notification Critical | 22 May, 2023 | US8293752 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 May, 2023 | US8293752 |
FDA has granted several exclusivities to Ojemda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ojemda, 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 Ojemda.
Exclusivity Information
Ojemda holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Ojemda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 23, 2029 |
| Orphan Drug Exclusivity(ODE-478) | Apr 23, 2031 |
US patents provide insights into the exclusivity only within the United States, but Ojemda 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 Ojemda's family patents as well as insights into ongoing legal events on those patents.
Ojemda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ojemda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 23, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ojemda Generics:
There are no approved generic versions for Ojemda as of now.
About Ojemda
Ojemda is a drug owned by Day One Biopharmaceuticals Inc. Ojemda uses Tovorafenib as an active ingredient. Ojemda was launched by Day One Biopharms in 2024.
Approval Date:
Ojemda was approved by FDA for market use on 23 April, 2024.
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 Ojemda is 23 April, 2024, its NCE-1 date is estimated to be 23 April, 2028.
Active Ingredient:
Ojemda uses Tovorafenib as the active ingredient. Check out other Drugs and Companies using Tovorafenib ingredient
Dosage:
Ojemda is available in the following dosage forms - tablet form for oral use, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 25MG/ML | FOR SUSPENSION | Prescription | ORAL |