apomorphine hydrochloride · Sumitomo Pharma Am · NDA 210875

Kynmobi

Earliest generic entry, as listed · earliest of 5 marketed strengths
19 Apr 2036

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

Blocked by patent: US 10449146, US 10959943. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 12 unexpired

PatentClaimsExpires
US 10449146use U-2825 · sets the listed date19 Apr 2036
US 10959943use U-2825 · sets the listed date19 Apr 2036
US 11419769drug product, use U-282516 Dec 2031
US 8414922drug product, use U-282516 Dec 2031
US 8846074drug product, use U-282516 Dec 2031
US 10420763drug product, use U-282511 Jun 2030
US 9044475drug product11 Jun 2030
US 9283219drug product, use U-282511 Jun 2030
US 9326981use U-282511 Jun 2030
US 9669019drug product, use U-282511 Jun 2030
US 9669021use U-282511 Jun 2030
US 10821074drug product7 Aug 2029

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 · 5

NDA · productFormStrengthListed expiry
210875 · 001 · RLD · discontinuedfilm, sublingual10MG19 Apr 2036
210875 · 002 · RLD · discontinuedfilm, sublingual15MG19 Apr 2036
210875 · 003 · RLD · discontinuedfilm, sublingual20MG19 Apr 2036
210875 · 004 · RLD · discontinuedfilm, sublingual25MG19 Apr 2036
210875 · 005 · RLD · discontinuedfilm, sublingual30MG19 Apr 2036