Ukoniq is a drug owned by Tg Therapeutics Inc. It is protected by 8 US drug patents filed from 2021 to 2022 out of which none have expired yet. Ukoniq's patents will be open to challenges from 05 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be May 26, 2035. Details of Ukoniq'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. | |||
| US9969740 | Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations |
May, 2035
(10 years from now) | Active |
| US10414773 | Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations |
May, 2035
(10 years from now) | Active |
| US10570142 | Selective PI3K delta inhibitors |
Jul, 2033
(8 years from now) | Active |
| US9150579 | Selective PI3K delta inhibitors |
Jul, 2033
(8 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). | |||
| US10947244 | Forms of a PI3K delta selective inhibitor for use in pharmaceutical formulations |
May, 2035
(10 years from now) | Active |
| US9669033 | Selective PI3K delta inhibitors |
Jul, 2033
(8 years from now) | Active |
| US10072013 | Selective PI3K delta inhibitors |
Jul, 2033
(8 years from now) | Active |
| US10981919 | Selective PI3K delta inhibitors |
Jul, 2033
(8 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 Ukoniq's patents.
Latest Legal Activities on Ukoniq's Patents
Given below is the list of recent legal activities going on the following patents of Ukoniq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9669033 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US10570142 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9150579 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US10072013 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Jan, 2024 | US10570142 |
| Surcharge for late Payment, Small Entity | 08 Jan, 2024 | US10570142 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US10072013 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US10570142 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9150579 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9669033 |
FDA has granted several exclusivities to Ukoniq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ukoniq, 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 Ukoniq.
Exclusivity Information
Ukoniq holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Ukoniq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 05, 2026 |
| Orphan Drug Exclusivity(ODE-343) | Feb 05, 2028 |
| Orphan Drug Exclusivity(ODE-344) | Feb 05, 2028 |
US patents provide insights into the exclusivity only within the United States, but Ukoniq 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 Ukoniq's family patents as well as insights into ongoing legal events on those patents.
Ukoniq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ukoniq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ukoniq Generics:
There are no approved generic versions for Ukoniq as of now.
About Ukoniq
Ukoniq is a drug owned by Tg Therapeutics Inc. It is used for treating relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL) after multiple prior lines of systemic therapy. Ukoniq uses Umbralisib Tosylate as an active ingredient. Ukoniq was launched by Tg Theraps in 2021.
Approval Date:
Ukoniq was approved by FDA for market use on 05 February, 2021.
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 Ukoniq is 05 February, 2021, its NCE-1 date is estimated to be 05 February, 2025.
Active Ingredient:
Ukoniq uses Umbralisib Tosylate as the active ingredient. Check out other Drugs and Companies using Umbralisib Tosylate ingredient
Treatment:
Ukoniq is used for treating relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL) after multiple prior lines of systemic therapy.
Dosage:
Ukoniq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Discontinued | ORAL |