Turalio is a drug owned by Daiichi Sankyo Inc. It is protected by 12 US drug patents filed from 2019 to 2022 out of which none have expired yet. Turalio's patents have been open to challenges since 03 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 24, 2038. Details of Turalio'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. | |||
| US9802932 | Solid forms of a compound modulating kinases |
May, 2036
(11 years from now) | Active |
| US10730876 | Synthesis of a compound that modulates kinases |
May, 2036
(11 years from now) | Active |
| US7893075 | Compounds modulating c-fms and/or c-kit activity and uses therefor |
May, 2033
(8 years from now) | Active |
| US9169250 | Compounds modulating c-fms and/or c-kit activity and uses therefor |
Nov, 2027
(2 years from now) | Active |
| US8404700 | Compounds modulating c-fms and/or c-kit activity and uses therefor |
Nov, 2027
(2 years from now) | Active |
| US8722702 | Compounds modulating c-fms and/or c-kit activity and uses therefor |
Nov, 2027
(2 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). | |||
| US10435404 | Formulations of a compound modulating kinases |
Jul, 2038
(13 years from now) | Active |
| US10961240 | Formulations of a compound modulating kinases |
Jul, 2038
(13 years from now) | Active |
| US10941142 | Formulations of a compound modulating kinases |
Jul, 2038
(13 years from now) | Active |
| US10189833 | Solid forms of a compound modulating kinases |
May, 2036
(11 years from now) | Active |
| US9358235 | Kinase modulation, and indications therefor |
Jun, 2033
(8 years from now) | Active |
| US8461169 | Compounds modulating c-fms and/or c-kit activity |
Apr, 2028
(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 Turalio's patents.
Latest Legal Activities on Turalio's Patents
Given below is the list of recent legal activities going on the following patents of Turalio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Feb, 2024 | US10730876 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2023 | US9169250 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Apr, 2023 | US10435404 |
| Patent Term Extension Certificate Critical | 06 Oct, 2022 | US7893075 |
| Withdrawal of Application for PTE Critical | 30 Aug, 2022 | US8461169 |
| Withdrawal of Application for PTE Critical | 30 Aug, 2022 | US9169250 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Aug, 2022 | US7893075 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Aug, 2022 | US10435404 |
| Filing Receipt - Corrected | 09 Aug, 2022 | US10189833 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Aug, 2022 | US10730876 |
FDA has granted several exclusivities to Turalio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Turalio, 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 Turalio.
Exclusivity Information
Turalio holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Turalio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 02, 2024 |
| ODE*(ODE*) | Aug 02, 2026 |
| Orphan Drug Exclusivity(ODE-250) | Aug 02, 2026 |
US patents provide insights into the exclusivity only within the United States, but Turalio 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 Turalio's family patents as well as insights into ongoing legal events on those patents.
Turalio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Turalio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 24, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Turalio Generics:
There are no approved generic versions for Turalio as of now.
About Turalio
Turalio is a drug owned by Daiichi Sankyo Inc. It is used for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations that are not improved with surgery. Turalio uses Pexidartinib Hydrochloride as an active ingredient. Turalio was launched by Daiichi Sankyo Inc in 2022.
Approval Date:
Turalio was approved by FDA for market use on 14 October, 2022.
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 Turalio is 14 October, 2022, its NCE-1 date is estimated to be 03 August, 2023.
Active Ingredient:
Turalio uses Pexidartinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Pexidartinib Hydrochloride ingredient
Treatment:
Turalio is used for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations that are not improved with surgery.
Dosage:
Turalio is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 125MG BASE | CAPSULE | Prescription | ORAL |
| EQ 200MG BASE | CAPSULE | Discontinued | ORAL |