Orange Book product · Brand (NDA)
RYTARY
CARBIDOPA; LEVODOPA
At a glance
Jan 07, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 2015
11 yr 7 mo ago
Today
Patent 8377474 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8377474 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8454998 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8454998 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8454998 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8454998 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8454998 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8557283 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 8557283 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9089607 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9089607 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9089608 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9463246 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9533046 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Patent 9901640 expires
Listed drug product patent expiration.
Dec 26, 2028
in 2 yr 7 mo
Pharmaceutical detail
Active ingredient
CARBIDOPA; LEVODOPA
Strength
48.75MG;195MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 203312
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024CREXONTBrand (NDA)
NDA 217186 · IMPAX
- 2021DHIVYBrand (NDA)
NDA 214869 · AVION PHARMS
- 2015DUOPABrand (NDA)
NDA 203952 · ABBVIE
- 1992SINEMET CRBrand (NDA)
NDA 019856 · ORGANON LLC
- —SINEMETBrand (NDA)
NDA 017555 · ORGANON
- 2025CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 218939 · ASCENT PHARMS INC
- 2024CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 217482 · RUBICON RESEARCH
- 2023CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 215999 · ZYDUS PHARMS
- 2022CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 216537 · AUROBINDO PHARMA LTD
- 2022CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 216505 · RUBICON RESEARCH
- 2021CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 214091 · SCIEGEN PHARMS
- 2021CARBIDOPA AND LEVODOPAGeneric (ANDA)
ANDA 214092 · SCIEGEN PHARMS
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8377474 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
| 8377474 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1645 |
| 8454998 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1645 |
| 8454998 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1647 |
| 8454998 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1649 |
| 8454998 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
| 8454998 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1646 |
| 8557283 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1645 |
| 8557283 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
| 9089607 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1645 |
| 9089607 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-1720 |
| 9089608 | Dec 26, 2028 | in 2 yr 7 mo | Product |
| 9463246 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
| 9533046 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
| 9901640 | Dec 26, 2028 | in 2 yr 7 mo | ProductU-219 |
