dasatinib · Handa Therap · NDA 216099
Phyrago
Blocked by patent: US 11202778, US 11298356, US 11324745, US 12433891, US 12465606, US 12544376.
FDA has approved 2 generic applications (ANDAs) for Phyrago, though its earliest generic-entry date is 22 Jan 2041 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 6 unexpired
20 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11202778 | use U-3770, U-3771, U-3772 | 22 Jan 2041 |
| US 11202778 listing row | use U-3770 · sets the listed date | 22 Jan 2041 |
| US 11202778 listing row | use U-3771 · sets the listed date | 22 Jan 2041 |
| US 11202778 listing row | use U-3772 · sets the listed date | 22 Jan 2041 |
| US 11298356 | drug product · sets the listed date | 22 Jan 2041 |
| US 11324745 | use U-3767, U-3768, U-3769 | 22 Jan 2041 |
| US 11324745 listing row | use U-3767 · sets the listed date | 22 Jan 2041 |
| US 11324745 listing row | use U-3768 · sets the listed date | 22 Jan 2041 |
| US 11324745 listing row | use U-3769 · sets the listed date | 22 Jan 2041 |
| US 12433891 | use U-3767, U-3768, U-3769, U-3770, U-3771, U-3772 | 22 Jan 2041 |
| US 12433891 listing row | use U-3767 · sets the listed date | 22 Jan 2041 |
| US 12433891 listing row | use U-3768 · sets the listed date | 22 Jan 2041 |
| US 12433891 listing row | use U-3769 · sets the listed date | 22 Jan 2041 |
| US 12433891 listing row | use U-3770 · sets the listed date | 22 Jan 2041 |
| US 12433891 listing row | use U-3771 · sets the listed date | 22 Jan 2041 |
| US 12433891 listing row | use U-3772 · sets the listed date | 22 Jan 2041 |
| US 12465606 | drug product · sets the listed date | 22 Jan 2041 |
| US 12544376 | use U-3767, U-3768, U-3769, U-3770, U-3771, U-3772 | 22 Jan 2041 |
| US 12544376 listing row | use U-3767 · sets the listed date | 22 Jan 2041 |
| US 12544376 listing row | use U-3768 · sets the listed date | 22 Jan 2041 |
| US 12544376 listing row | use U-3769 · sets the listed date | 22 Jan 2041 |
| US 12544376 listing row | use U-3770 · sets the listed date | 22 Jan 2041 |
| US 12544376 listing row | use U-3771 · sets the listed date | 22 Jan 2041 |
| US 12544376 listing row | use U-3772 · sets the listed date | 22 Jan 2041 |
Exclusivities · 1 unexpired
| M-307 | miscellaneous (3 years) | 5 Dec 2026 |
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
- 25 Oct 2026Generic approved · 216099-0016 Nov 2025
- 25 Oct 2026Generic approved · 216099-00111 Sep 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0065 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0055 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0045 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0035 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0025 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days M-307 · 216099-0015 Dec 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216099 · 001 · RLD | tablet, oral | 20MG | 22 Jan 2041 |
| 216099 · 002 · RLD | tablet, oral | 50MG | 22 Jan 2041 |
| 216099 · 003 · RLD | tablet, oral | 70MG | 22 Jan 2041 |
| 216099 · 004 · RLD | tablet, oral | 80MG | 22 Jan 2041 |
| 216099 · 005 · RLD | tablet, oral | 100MG | 22 Jan 2041 |
| 216099 · 006 · RLD | tablet, oral | 140MG | 22 Jan 2041 |