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 8454998, US 8557283, US 9089607, US 9089608, US 9463246, US 9533046, US 9901640.
Listed patents · 8 unexpired
15 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8377474 | drug product, use U-1645, U-219 | 26 Dec 2028 |
| US 8377474 listing row | drug product, use U-1645 · sets the listed date | 26 Dec 2028 |
| US 8377474 listing row | drug product, use U-219 · sets the listed date | 26 Dec 2028 |
| US 8454998 | drug product, use U-1645, U-1646, U-1647, U-1649, U-219 | 26 Dec 2028 |
| US 8454998 listing row | drug product, use U-1645 · sets the listed date | 26 Dec 2028 |
| US 8454998 listing row | drug product, use U-1646 · sets the listed date | 26 Dec 2028 |
| US 8454998 listing row | drug product, use U-1647 · sets the listed date | 26 Dec 2028 |
| US 8454998 listing row | drug product, use U-1649 · sets the listed date | 26 Dec 2028 |
| US 8454998 listing row | drug product, use U-219 · sets the listed date | 26 Dec 2028 |
| US 8557283 | drug product, use U-1645, U-219 | 26 Dec 2028 |
| US 8557283 listing row | drug product, use U-1645 · sets the listed date | 26 Dec 2028 |
| US 8557283 listing row | drug product, use U-219 · sets the listed date | 26 Dec 2028 |
| US 9089607 | drug product, use U-1645, U-1720 | 26 Dec 2028 |
| US 9089607 listing row | drug product, use U-1645 · sets the listed date | 26 Dec 2028 |
| US 9089607 listing row | drug product, use U-1720 · sets the listed date | 26 Dec 2028 |
| US 9089608 | drug product · sets the listed date | 26 Dec 2028 |
| US 9463246 | drug product, use U-219 · sets the listed date | 26 Dec 2028 |
| US 9533046 | drug product, use U-219 · sets the listed date | 26 Dec 2028 |
| US 9901640 | drug product, use U-219 · sets the listed date | 26 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 · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203312 · 001 · RLD | capsule, extended release, oral | 23.75MG;95MG | 26 Dec 2028 |
| 203312 · 002 · RLD | capsule, extended release, oral | 36.25MG;145MG | 26 Dec 2028 |
| 203312 · 003 · RLD | capsule, extended release, oral | 48.75MG;195MG | 26 Dec 2028 |
| 203312 · 004 · RLD | capsule, extended release, oral | 61.25MG;245MG | 26 Dec 2028 |