cliffwatch

carbidopa; levodopa · Impax · NDA 203312

Rytary

Earliest generic entry, as listed · earliest of 4 marketed strengths
26 Dec 2028

Blocked by patent: US 8377474, US 8377474, US 8454998, US 8454998, US 8454998, US 8454998, US 8454998, US 8557283, US 8557283, US 9089607, US 9089607, US 9089608, US 9463246, US 9533046, US 9901640.

Listed patents · 15 unexpired

PatentClaimsExpires
US 8377474product, use U-21926 Dec 2028
US 8377474product, use U-164526 Dec 2028
US 8454998product, use U-164726 Dec 2028
US 8454998product, use U-164626 Dec 2028
US 8454998product, use U-164926 Dec 2028
US 8454998product, use U-21926 Dec 2028
US 8454998product, use U-164526 Dec 2028
US 8557283product, use U-21926 Dec 2028
US 8557283product, use U-164526 Dec 2028
US 9089607product, use U-172026 Dec 2028
US 9089607product, use U-164526 Dec 2028
US 9089608product26 Dec 2028
US 9463246product, use U-21926 Dec 2028
US 9533046product, use U-21926 Dec 2028
US 9901640product, use U-21926 Dec 2028

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
203312 · 001 · RLDcapsule, extended release, oral23.75MG;95MG26 Dec 2028
203312 · 002 · RLDcapsule, extended release, oral36.25MG;145MG26 Dec 2028
203312 · 003 · RLDcapsule, extended release, oral48.75MG;195MG26 Dec 2028
203312 · 004 · RLDcapsule, extended release, oral61.25MG;245MG26 Dec 2028