cliffwatch

cysteamine bitartrate · Horizon · NDA 203389, 213491

Procysbi

Earliest generic entry, as listed · earliest of 4 marketed strengths
16 Feb 2037

Blocked by patent: US 10143665, US 10328037, US 10548859, US 10905662.

Listed patents · 24 unexpired

PatentClaimsExpires
US 10143665—16 Feb 2037
US 10328037—16 Feb 2037
US 10548859—16 Feb 2037
US 10905662—16 Feb 2037
US 10143665use U-139916 Aug 2036
US 10328037use U-139916 Aug 2036
US 10548859use U-139916 Aug 2036
US 10905662use U-139916 Aug 2036
US 9173851—17 Dec 2034
US 9233077—17 Dec 2034
US 9173851product17 Jun 2034
US 9233077product17 Jun 2034
US 8026284—22 Mar 2028
US 8026284use U-139922 Sep 2027
US 9192590—26 Jul 2027
US 9198882—26 Jul 2027
US 9925156—26 Jul 2027
US 9925157—26 Jul 2027
US 9925158—26 Jul 2027
US 9192590use U-139926 Jan 2027
US 9198882use U-139926 Jan 2027
US 9925156substance, product, use U-139926 Jan 2027
US 9925157product, use U-139926 Jan 2027
US 9925158substance, product, use U-139926 Jan 2027

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 · 4

NDA · productFormStrengthListed expiry
203389 · 001 · RLDcapsule, delayed release, oralEQ 25MG BASE16 Feb 2037
203389 · 002 · RLDcapsule, delayed release, oralEQ 75MG BASE16 Feb 2037
213491 · 001 · RLDgranule, delayed release, oralEQ 75MG BASE/PACKET16 Feb 2037
213491 · 002 · RLDgranule, delayed release, oralEQ 300MG BASE/PACKET16 Feb 2037