FDA Orange Book
Is there a generic for Icotyde?
Icotyde contains icotrokinra. 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 Icotyde (icotrokinra). The Orange Book shows its last listed patent expires November 19, 2041 and its last listed exclusivity ends March 17, 2031.
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Icotyde products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 220149, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Icotyde patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12552836 | July 12, 2039 | Drug substance, Drug product | None | 220149 |
| 11845808 | January 14, 2041 | Drug substance | U-4447 | 220149 |
| 11939361 | November 19, 2041 | Drug product | U-4447 | 220149 |
Icotyde exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 17, 2031 | 220149 |
Icotyde NDC codes
Questions
Is there a generic for Icotyde?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Icotyde (icotrokinra). The Orange Book shows its last listed patent expires November 19, 2041 and its last listed exclusivity ends March 17, 2031.
What is the generic name for Icotyde?
The active ingredient in Icotyde is icotrokinra, per the FDA Orange Book.
When does the Icotyde patent expire?
The last patent listed for Icotyde in the Orange Book expires November 19, 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.