FDA Orange Book
Is there a generic for Rytary?
Rytary contains carbidopa and levodopa. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rytary (carbidopa and levodopa). The Orange Book shows its last listed patent expires December 26, 2028.
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Rytary products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 23.75MG;95MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 36.25MG;145MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 48.75MG;195MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 61.25MG;245MG | Marketed (Rx) | None | 0 | None |
NDA 203312, held by IMPAX LABORATORIES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rytary patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9089607 | December 26, 2028 | Drug product | U-1645 | 203312 |
| 8377474 | December 26, 2028 | Drug product | U-219 | 203312 |
| 8377474 | December 26, 2028 | Drug product | U-1645 | 203312 |
| 8454998 | December 26, 2028 | Drug product | U-1645 | 203312 |
| 8454998 | December 26, 2028 | Drug product | U-1649 | 203312 |
| 8454998 | December 26, 2028 | Drug product | U-1646 | 203312 |
| 9089607 | December 26, 2028 | Drug product | U-1720 | 203312 |
| 8557283 | December 26, 2028 | Drug product | U-219 | 203312 |
| 9901640 | December 26, 2028 | Drug product | U-219 | 203312 |
| 8454998 | December 26, 2028 | Drug product | U-1647 | 203312 |
| 8557283 | December 26, 2028 | Drug product | U-1645 | 203312 |
| 8454998 | December 26, 2028 | Drug product | U-219 | 203312 |
| 9533046 | December 26, 2028 | Drug product | U-219 | 203312 |
| 9463246 | December 26, 2028 | Drug product | U-219 | 203312 |
| 9089608 | December 26, 2028 | Drug product | None | 203312 |
Rytary NDC codes
Questions
Is there a generic for Rytary?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rytary (carbidopa and levodopa). The Orange Book shows its last listed patent expires December 26, 2028.
What is the generic name for Rytary?
The active ingredient in Rytary is carbidopa and levodopa, per the FDA Orange Book.
When does the Rytary patent expire?
The last patent listed for Rytary in the Orange Book expires December 26, 2028. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.