monomethyl fumarate · Banner Life Sciences · NDA 210296
Bafiertam
Earliest generic entry, as listed
27 Feb 2035
Blocked by patent: US 10098863, US 10105335, US 10105336, US 10105337, US 10918615, US 10918616, US 10918617, US 10945985, US 11590095, US 11903918, US 9326947, US 9326965, US 9511043, US 9517209, US 9566259, US 9636318, US 9636319, US 9814691, US 9814692, US 9820960, US 9820961.
Listed patents · 21 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10098863 | product, use U-1384 | 27 Feb 2035 |
| US 10105335 | product | 27 Feb 2035 |
| US 10105336 | product, use U-1384 | 27 Feb 2035 |
| US 10105337 | product | 27 Feb 2035 |
| US 10918615 | product, use U-1384 | 27 Feb 2035 |
| US 10918616 | use U-1384 | 27 Feb 2035 |
| US 10918617 | product | 27 Feb 2035 |
| US 10945985 | product | 27 Feb 2035 |
| US 11590095 | use U-1384 | 27 Feb 2035 |
| US 11903918 | use U-1384 | 27 Feb 2035 |
| US 9326947 | product | 27 Feb 2035 |
| US 9326965 | use U-1384 | 27 Feb 2035 |
| US 9511043 | use U-1384 | 27 Feb 2035 |
| US 9517209 | product | 27 Feb 2035 |
| US 9566259 | product | 27 Feb 2035 |
| US 9636318 | use U-1384 | 27 Feb 2035 |
| US 9636319 | product | 27 Feb 2035 |
| US 9814691 | use U-1384 | 27 Feb 2035 |
| US 9814692 | use U-1384 | 27 Feb 2035 |
| US 9820960 | product | 27 Feb 2035 |
| US 9820961 | product, use U-1384 | 27 Feb 2035 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210296 · 001 · RLD | capsule, delayed release, oral | 95MG | 27 Feb 2035 |