cliffwatch

carbidopa; levodopa · Impax · NDA 217186

Crexont

Earliest generic entry, as listed · earliest of 4 marketed strengths
21 Dec 2041

Blocked by patent: US 11986449, US 12109185, US 12194150, US 12201596, US 12263148, US 12263149, US 12295931, US 12303481, US 12303482, US 12370163, US 12447139, US 12453710, US 12458616. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 30 unexpired

62 Orange Book listing rows for 30 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11986449use U-219 · sets the listed date21 Dec 2041
US 12109185use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12109185 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12109185 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12109185 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12109185 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12194150use U-219 · sets the listed date21 Dec 2041
US 12201596use U-1649, U-4004, U-400521 Dec 2041
US 12201596 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12201596 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12201596 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12263148use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12263148 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12263148 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12263148 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12263148 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12263149use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12263149 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12263149 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12263149 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12263149 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12295931use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12295931 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12295931 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12295931 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12295931 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12303481use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12303481 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12303481 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12303481 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12303481 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12303482use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12303482 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12303482 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12303482 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12303482 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12370163use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12370163 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12370163 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12370163 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12370163 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12447139use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12447139 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12447139 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12447139 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12447139 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12453710use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12453710 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12453710 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12453710 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12453710 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 12458616use U-1649, U-219, U-4004, U-400521 Dec 2041
US 12458616 listing rowuse U-1649 · sets the listed date21 Dec 2041
US 12458616 listing rowuse U-219 · sets the listed date21 Dec 2041
US 12458616 listing rowuse U-4004 · sets the listed date21 Dec 2041
US 12458616 listing rowuse U-4005 · sets the listed date21 Dec 2041
US 10098845drug product, use U-2197 Oct 2034
US 10292935drug product, use U-2197 Oct 2034
US 10688058drug product, use U-2197 Oct 2034
US 10973769drug product, use U-2197 Oct 2034
US 10987313drug product, use U-2197 Oct 2034
US 11357733drug product7 Oct 2034
US 11622941drug product7 Oct 2034
US 11666538drug product, use U-2197 Oct 2034
US 12064521drug product7 Oct 2034
US 12128141drug product, use U-2197 Oct 2034
US 12178918drug product7 Oct 2034
US 12178919drug product, use U-2197 Oct 2034
US 12274793drug product7 Oct 2034
US 12303605drug product7 Oct 2034
US 12403099drug product7 Oct 2034
US 12491164drug product7 Oct 2034
US 12691074drug product7 Oct 2034

Exclusivities · 1 unexpired

NPnew product7 Aug 2027

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
217186 · 001 · RLDcapsule, extended release, oral35MG;140MG21 Dec 2041
217186 · 002 · RLDcapsule, extended release, oral52.5MG;210MG21 Dec 2041
217186 · 003 · RLDcapsule, extended release, oral70MG;280MG21 Dec 2041
217186 · 004 · RLDcapsule, extended release, oral87.5MG;350MG21 Dec 2041