tipiracil hydrochloride; trifluridine · Taiho Oncology · NDA 207981
Lonsurf
Earliest generic entry, as listed · earliest of 2 marketed strengths
3 Feb 2037
Blocked by patent: US 10456399, US 10960004, US 12728130.
Listed patents · 7 unexpired
12 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10456399 | use U-3657, U-3658 | 3 Feb 2037 |
| US 10456399 listing row | use U-3657 · sets the listed date | 3 Feb 2037 |
| US 10456399 listing row | use U-3658 · sets the listed date | 3 Feb 2037 |
| US 10960004 | use U-3657, U-3658 | 3 Feb 2037 |
| US 10960004 listing row | use U-3657 · sets the listed date | 3 Feb 2037 |
| US 10960004 listing row | use U-3658 · sets the listed date | 3 Feb 2037 |
| US 12728130 | drug product, use U-3657, U-3658 | 3 Feb 2037 |
| US 12728130 listing row | drug product, use U-3657 · sets the listed date | 3 Feb 2037 |
| US 12728130 listing row | drug product, use U-3658 · sets the listed date | 3 Feb 2037 |
| US 9943537 | use U-3659 | 5 Sep 2034 |
| US 10457666 | drug substance, drug product | 17 Jun 2034 |
| US 9527833 | drug substance, drug product | 17 Jun 2034 |
| US RE46284 | use U-1751, U-2503, U-3656 | 22 Sep 2029 |
| US RE46284 listing row | use U-1751 | 22 Sep 2029 |
| US RE46284 listing row | use U-2503 | 22 Sep 2029 |
| US RE46284 listing row | use U-3656 | 22 Sep 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207981 · 001 · RLD | tablet, oral | EQ 6.14MG BASE;15MG | 3 Feb 2037 |
| 207981 · 002 · RLD | tablet, oral | EQ 8.19MG BASE;20MG | 3 Feb 2037 |
Expired or delisted (1)
- ODE-229 · 22 Feb 2026