FDA Orange Book
Is there a generic for Foundayo?
Foundayo contains orforglipron. 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 Foundayo (orforglipron). The Orange Book shows its last listed patent expires September 26, 2037 and its last listed exclusivity ends April 1, 2031.
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Foundayo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.8MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 14.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 17.2MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 2.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 5.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 9MG BASE | Marketed (Rx) | None | 0 | None |
NDA 220934, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Foundayo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE50455 | September 26, 2037 | Drug substance, Drug product | U-4474 | 220934 |
Foundayo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 1, 2031 | 220934 |
Foundayo NDC codes
Questions
Is there a generic for Foundayo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Foundayo (orforglipron). The Orange Book shows its last listed patent expires September 26, 2037 and its last listed exclusivity ends April 1, 2031.
What is the generic name for Foundayo?
The active ingredient in Foundayo is orforglipron, per the FDA Orange Book.
When does the Foundayo patent expire?
The last patent listed for Foundayo in the Orange Book expires September 26, 2037. 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.