FDA Orange Book
Is there a generic for Mycapssa?
Mycapssa contains octreotide acetate. 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 Mycapssa (octreotide acetate). The Orange Book shows its last listed patent expires December 28, 2040 and its last listed exclusivity ends June 26, 2027.
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Mycapssa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208232, held by CHIESI FARMACEUTICI SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mycapssa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8535695 | September 17, 2029 | Method of use | U-2857 | 208232 |
| 11986529 | September 17, 2029 | Method of use | U-2857 | 208232 |
| 11969471 | September 17, 2029 | Drug product | None | 208232 |
| 8329198 | September 17, 2029 | Drug product | None | 208232 |
| 9265812 | September 17, 2029 | Drug product | None | 208232 |
| 9566246 | September 17, 2029 | Drug product | None | 208232 |
| 11338011 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 12251418 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 12246054 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 10695397 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 10238709 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 11510963 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 11052126 | February 3, 2036 | Method of use | U-2857 | 208232 |
| 11857595 | February 3, 2036 | Method of use | U-3784 | 208232 |
| 11141457 | December 28, 2040 | Method of use | U-3232 | 208232 |
| 11890316 | December 28, 2040 | Method of use | U-3232 | 208232 |
Mycapssa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-474 | Orphan drug exclusivity | June 26, 2027 | 208232 |
Mycapssa NDC codes
Questions
Is there a generic for Mycapssa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mycapssa (octreotide acetate). The Orange Book shows its last listed patent expires December 28, 2040 and its last listed exclusivity ends June 26, 2027.
What is the generic name for Mycapssa?
The active ingredient in Mycapssa is octreotide acetate, per the FDA Orange Book.
When does the Mycapssa patent expire?
The last patent listed for Mycapssa in the Orange Book expires December 28, 2040. 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.