FDA Orange Book
Is there a generic for Cobenfy?
Cobenfy contains xanomeline and trospium chloride. 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 Cobenfy (xanomeline and trospium chloride). The Orange Book shows its last listed patent expires October 29, 2039 and its last listed exclusivity ends September 26, 2029.
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Cobenfy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 20MG;EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | 20MG;EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | 30MG;EQ 125MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216158, held by BRISTOL-MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cobenfy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10695339 | July 21, 2030 | Method of use | U-3513 | 216158 |
| 10369144 | July 21, 2030 | Drug product | U-3513 | 216158 |
| 10369143 | July 21, 2030 | Method of use | U-3513 | 216158 |
| 10265311 | July 21, 2030 | Method of use | U-3513 | 216158 |
| 10238643 | July 21, 2030 | Drug product | None | 216158 |
| 11890378 | September 27, 2039 | Drug product | U-3513 | 216158 |
| 11471413 | September 27, 2039 | Method of use | U-3513 | 216158 |
| 11452692 | September 27, 2039 | Method of use | U-3513 | 216158 |
| 10933020 | September 27, 2039 | Drug product | U-3513 | 216158 |
| 10925832 | September 27, 2039 | Drug product | None | 216158 |
| 12558317 | October 29, 2039 | Drug product | None | 216158 |
Cobenfy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 26, 2029 | 216158 |
Cobenfy NDC codes
Questions
Is there a generic for Cobenfy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cobenfy (xanomeline and trospium chloride). The Orange Book shows its last listed patent expires October 29, 2039 and its last listed exclusivity ends September 26, 2029.
What is the generic name for Cobenfy?
The active ingredient in Cobenfy is xanomeline and trospium chloride, per the FDA Orange Book.
When does the Cobenfy patent expire?
The last patent listed for Cobenfy in the Orange Book expires October 29, 2039. 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.