FDA Orange Book
Is there a generic for Symproic?
Symproic contains naldemedine. 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 Symproic (naldemedine). The Orange Book shows its last listed patent expires May 13, 2033.
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Symproic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.2MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208854, held by BIODELIVERY SCIENCES INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Symproic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE46375 | October 5, 2026 | Drug substance, Drug product | U-1185 | 208854 |
| RE46365 | February 24, 2031 | Drug substance, Drug product | None | 208854 |
| 9108975 | November 11, 2031 | Drug substance, Drug product | None | 208854 |
| 10952968 | May 13, 2033 | Drug substance, Drug product | None | 208854 |
| 12350377 | May 13, 2033 | Drug product | None | 208854 |
Symproic NDC codes
Questions
Is there a generic for Symproic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symproic (naldemedine). The Orange Book shows its last listed patent expires May 13, 2033.
What is the generic name for Symproic?
The active ingredient in Symproic is naldemedine, per the FDA Orange Book.
When does the Symproic patent expire?
The last patent listed for Symproic in the Orange Book expires May 13, 2033. 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.