Lonsurf is a drug owned by Taiho Oncology Inc. It is protected by 9 US drug patents filed from 2015 to 2023. Out of these, 7 drug patents are active and 2 have expired. Lonsurf's patents have been open to challenges since 23 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2037. Details of Lonsurf'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. | |||
| US9527833 | Stable crystal form of tipiracil hydrochloride and crystallization method for the same |
Jun, 2034
(9 years from now) | Active |
| US10457666 | Stable crystal form of tipiracil hydrochloride and crystallization method for the same |
Jun, 2034
(9 years from now) | Active |
| US5744475 | Uracil derivatives, and antitumor effect potentiator and antitumor agent containing the same |
Mar, 2016
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10456399 | Method for treating cancer patients with severe renal impairment |
Feb, 2037
(12 years from now) | Active |
| US10960004 | Method for treating cancer patients with severe renal impairment |
Feb, 2037
(12 years from now) | Active |
| US9943537 | Antitumor agent and antitumor effect enhancer |
Sep, 2034
(9 years from now) | Active |
| USRE46284 | Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor |
Sep, 2029
(4 years from now) | Active |
| US7799783 | Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor |
Dec, 2026
(2 years from now) | Active |
| US6479500 | Agents for alleviating side effects |
Mar, 2020
(4 years ago) |
Expired
|
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 Lonsurf's patents.
Latest Legal Activities on Lonsurf's Patents
Given below is the list of recent legal activities going on the following patents of Lonsurf.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jun, 2024 | US9527833 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2023 | US10456399 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2023 | US10457666 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Sep, 2021 | US9943537 |
| Recordation of Patent Grant Mailed Critical | 30 Mar, 2021 | US10960004 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Mar, 2021 | US10960004 |
| Email Notification Critical | 11 Mar, 2021 | US10960004 |
| Issue Notification Mailed Critical | 10 Mar, 2021 | US10960004 |
| Notice of Final Determination -Eligible | 05 Mar, 2021 | US7799783 |
| Dispatch to FDC | 03 Mar, 2021 | US10960004 |
FDA has granted several exclusivities to Lonsurf. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lonsurf, 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 Lonsurf.
Exclusivity Information
Lonsurf holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Lonsurf's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 22, 2020 |
| New Indication(I-794) | Feb 22, 2022 |
| Orphan Drug Exclusivity(ODE-229) | Feb 22, 2026 |
Several oppositions have been filed on Lonsurf's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Lonsurf's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lonsurf patents.
Lonsurf's Oppositions Filed in EPO
Lonsurf has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 13, 2022, by Stada Arzneimittel Ag. This opposition was filed on patent number EP14814354A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14814354A | Jul, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Lonsurf 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 Lonsurf's family patents as well as insights into ongoing legal events on those patents.
Lonsurf's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lonsurf's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lonsurf Generic API suppliers:
Tipiracil Hydrochloride; Trifluridine is the generic name for the brand Lonsurf. 1 company has already filed for the generic of Lonsurf. Check out the entire list of companies who have already received approval for Lonsurf's generic
How can I launch a generic of Lonsurf before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lonsurf's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lonsurf's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Lonsurf -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg/6.14 mg and 20 mg/8.19 mg | 23 Sep, 2019 | 4 | 13 Jun, 2023 | 17 Jun, 2034 | Deferred |
About Lonsurf
Lonsurf is a drug owned by Taiho Oncology Inc. It is used for treating metastatic colorectal cancer in patients previously treated with specific chemotherapy combinations. Lonsurf uses Tipiracil Hydrochloride; Trifluridine as an active ingredient. Lonsurf was launched by Taiho Oncology in 2015.
Approval Date:
Lonsurf was approved by FDA for market use on 22 September, 2015.
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 Lonsurf is 22 September, 2015, its NCE-1 date is estimated to be 23 September, 2019.
Active Ingredient:
Lonsurf uses Tipiracil Hydrochloride; Trifluridine as the active ingredient. Check out other Drugs and Companies using Tipiracil Hydrochloride; Trifluridine ingredient
Treatment:
Lonsurf is used for treating metastatic colorectal cancer in patients previously treated with specific chemotherapy combinations.
Dosage:
Lonsurf is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 6.14MG BASE;15MG | TABLET | Prescription | ORAL |
| EQ 8.19MG BASE;20MG | TABLET | Prescription | ORAL |