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

PatentClaimsExpires
US 10098863product, use U-138427 Feb 2035
US 10105335product27 Feb 2035
US 10105336product, use U-138427 Feb 2035
US 10105337product27 Feb 2035
US 10918615product, use U-138427 Feb 2035
US 10918616use U-138427 Feb 2035
US 10918617product27 Feb 2035
US 10945985product27 Feb 2035
US 11590095use U-138427 Feb 2035
US 11903918use U-138427 Feb 2035
US 9326947product27 Feb 2035
US 9326965use U-138427 Feb 2035
US 9511043use U-138427 Feb 2035
US 9517209product27 Feb 2035
US 9566259product27 Feb 2035
US 9636318use U-138427 Feb 2035
US 9636319product27 Feb 2035
US 9814691use U-138427 Feb 2035
US 9814692use U-138427 Feb 2035
US 9820960product27 Feb 2035
US 9820961product, use U-138427 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 · productFormStrengthListed expiry
210296 · 001 · RLDcapsule, delayed release, oral95MG27 Feb 2035