Lytgobi is a drug owned by Taiho Oncology Inc. It is protected by 3 US drug patents filed from 2022 to 2023 out of which none have expired yet. Lytgobi's patents will be open to challenges from 30 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 05, 2039. Details of Lytgobi'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. | |||
| US10434103 | Crystal of 3,5-disubstituted benzene alkynyl compound |
Mar, 2036
(11 years from now) | Active |
| US9108973 | 3,5-disubstituted alkynylbenzene compound and salt thereof |
Feb, 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). | |||
| US11833151 | Pharmaceutical composition including sodium alkyl sulfate |
Nov, 2039
(14 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 Lytgobi's patents.
Latest Legal Activities on Lytgobi's Patents
Given below is the list of recent legal activities going on the following patents of Lytgobi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Letter from FDA or Dept of Agriculture re PTE application | 11 Jun, 2024 | US9108973 |
| Letter from FDA or Dept of Agriculture re PTE application | 11 Jun, 2024 | US10434103 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Mar, 2024 | US11833151 |
| Email Notification Critical | 20 Mar, 2024 | US11833151 |
| Notice of Final Determination- Ineligible | 18 Mar, 2024 | US9108973 |
| Notice of Final Determination- Ineligible | 18 Mar, 2024 | US10434103 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US10434103 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US9108973 |
| Mail Patent eGrant Notification | 05 Dec, 2023 | US11833151 |
| Patent eGrant Notification | 05 Dec, 2023 | US11833151 |
FDA has granted several exclusivities to Lytgobi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lytgobi, 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 Lytgobi.
Exclusivity Information
Lytgobi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Lytgobi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 30, 2027 |
| Orphan Drug Exclusivity(ODE-410) | Sep 30, 2029 |
US patents provide insights into the exclusivity only within the United States, but Lytgobi 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 Lytgobi's family patents as well as insights into ongoing legal events on those patents.
Lytgobi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lytgobi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 05, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lytgobi Generics:
There are no approved generic versions for Lytgobi as of now.
About Lytgobi
Lytgobi is a drug owned by Taiho Oncology Inc. It is used for treating intrahepatic cholangiocarcinoma. Lytgobi uses Futibatinib as an active ingredient. Lytgobi was launched by Taiho Oncology in 2022.
Approval Date:
Lytgobi was approved by FDA for market use on 30 September, 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 Lytgobi is 30 September, 2022, its NCE-1 date is estimated to be 30 September, 2026.
Active Ingredient:
Lytgobi uses Futibatinib as the active ingredient. Check out other Drugs and Companies using Futibatinib ingredient
Treatment:
Lytgobi is used for treating intrahepatic cholangiocarcinoma.
Dosage:
Lytgobi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG | TABLET | Prescription | ORAL |