dimethyl fumarate · Biogen · NDA 204063
Tecfidera
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Nov 2035
Blocked by patent: US 10959972, US 11007166, US 11007167, US 11129806, US 11246850. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10959972 | use U-1384 | 16 Nov 2035 |
| US 11007166 | use U-1384 | 16 Nov 2035 |
| US 11007167 | use U-1384 | 16 Nov 2035 |
| US 11129806 | use U-1384 | 16 Nov 2035 |
| US 11246850 | use U-1384 | 16 Nov 2035 |
| US 10391160 | use U-3148 | 13 Mar 2035 |
| US 10555993 | use U-3148 | 13 Mar 2035 |
| US 10994003 | use U-3148 | 13 Mar 2035 |
| US 8399514 | use U-1384 | 7 Feb 2028 |
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 |
|---|---|---|---|
| 204063 · 001 · RLD | capsule, delayed release, oral | 120MG | 16 Nov 2035 |
| 204063 · 002 · RLD | capsule, delayed release, oral | 240MG | 16 Nov 2035 |