FDA Orange Book
Is there a generic for Crexont?
Crexont 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 Crexont (carbidopa and levodopa). The Orange Book shows its last listed patent expires December 21, 2041 and its last listed exclusivity ends August 7, 2027.
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Crexont products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 35MG;140MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 52.5MG;210MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 70MG;280MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 87.5MG;350MG | Marketed (Rx) | None | 0 | None |
NDA 217186, 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.
Crexont patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11666538 | October 7, 2034 | Drug product | U-219 | 217186 |
| 10987313 | October 7, 2034 | Drug product | U-219 | 217186 |
| 10973769 | October 7, 2034 | Drug product | U-219 | 217186 |
| 10688058 | October 7, 2034 | Drug product | U-219 | 217186 |
| 10292935 | October 7, 2034 | Drug product | U-219 | 217186 |
| 10098845 | October 7, 2034 | Drug product | U-219 | 217186 |
| 12178919 | October 7, 2034 | Drug product | U-219 | 217186 |
| 12128141 | October 7, 2034 | Drug product | U-219 | 217186 |
| 12274793 | October 7, 2034 | Drug product | None | 217186 |
| 12303605 | October 7, 2034 | Drug product | None | 217186 |
| 12403099 | October 7, 2034 | Drug product | None | 217186 |
| 12491164 | October 7, 2034 | Drug product | None | 217186 |
| 11622941 | October 7, 2034 | Drug product | None | 217186 |
| 12178918 | October 7, 2034 | Drug product | None | 217186 |
| 12064521 | October 7, 2034 | Drug product | None | 217186 |
| 11357733 | October 7, 2034 | Drug product | None | 217186 |
| 12691074 | October 7, 2034 | Drug product | None | 217186 |
| 12303482 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12303482 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12303482 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12303482 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12295931 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12295931 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12295931 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12295931 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12303481 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12303481 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12303481 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12303481 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 11986449 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12201596 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12201596 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12201596 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12109185 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12109185 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12109185 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12109185 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12458616 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12458616 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12458616 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12458616 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12453710 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12263148 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12263148 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12263148 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12263148 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12263149 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12263149 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12263149 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12263149 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12453710 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12453710 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12453710 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12447139 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12447139 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12447139 | December 21, 2041 | Method of use | U-4004 | 217186 |
| 12447139 | December 21, 2041 | Method of use | U-4005 | 217186 |
| 12194150 | December 21, 2041 | Method of use | U-219 | 217186 |
| 12370163 | December 21, 2041 | Method of use | U-1649 | 217186 |
| 12370163 | December 21, 2041 | Method of use | U-219 | 217186 |
Showing 60 of 62 listed patents.
Crexont exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | August 7, 2027 | 217186 |
Crexont NDC codes
Questions
Is there a generic for Crexont?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Crexont (carbidopa and levodopa). The Orange Book shows its last listed patent expires December 21, 2041 and its last listed exclusivity ends August 7, 2027.
What is the generic name for Crexont?
The active ingredient in Crexont is carbidopa and levodopa, per the FDA Orange Book.
When does the Crexont patent expire?
The last patent listed for Crexont in the Orange Book expires December 21, 2041. 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.