cliffwatch

methylphenidate hydrochloride · Knoa Pharma · NDA 212038

Adhansia Xr

Earliest generic entry, as listed · earliest of 6 marketed strengths
19 Nov 2038

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10722473. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 12 unexpired

PatentClaimsExpires
US 10722473use U-235719 Nov 2038
US 10111839use U-235730 Oct 2035
US 10292938product30 Oct 2035
US 10292939product, use U-235730 Oct 2035
US 10449159use U-235730 Oct 2035
US 10500162use U-235730 Oct 2035
US 10507186product30 Oct 2035
US 10512612product30 Oct 2035
US 10512613use U-235730 Oct 2035
US 10568841product, use U-235730 Oct 2035
US 10688060product30 Oct 2035
US 9974752product30 Oct 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 · 6

NDA · productFormStrengthListed expiry
212038 · 001 · RLD · discontinuedcapsule, extended release, oral25MG19 Nov 2038
212038 · 002 · RLD · discontinuedcapsule, extended release, oral35MG19 Nov 2038
212038 · 003 · RLD · discontinuedcapsule, extended release, oral45MG19 Nov 2038
212038 · 004 · RLD · discontinuedcapsule, extended release, oral55MG19 Nov 2038
212038 · 005 · RLD · discontinuedcapsule, extended release, oral70MG19 Nov 2038
212038 · 006 · RLD · discontinuedcapsule, extended release, oral85MG19 Nov 2038