FDA Orange Book
Generic for Olumiant
Olumiant contains baricitinib. 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
Yes. The generic name for Olumiant is baricitinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Olumiant products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 1 | AB |
NDA 207924, 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.
Approved generic baricitinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 217585 | AB (A-rated, therapeutically equivalent) | August 8, 2025 | 1MG, 2MG, 4MG |
Olumiant patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8420629 | March 10, 2029 | Method of use | U-247 | 207924 |
| 9737469 | November 2, 2031 | Method of use | U-3500 | 207924 |
| 11806555 | November 2, 2031 | Method of use | U-3500 | 207924 |
| 8158616 | May 31, 2032 | Drug substance, Drug product | None | 207924 |
| 11045474 | November 30, 2032 | Method of use | U-3372 | 207924 |
| 9089574 | November 30, 2032 | Method of use | U-3372 | 207924 |
Olumiant NDC codes
Questions
Is there a generic for Olumiant?
Yes. The generic name for Olumiant is baricitinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Olumiant?
The active ingredient in Olumiant is baricitinib, per the FDA Orange Book.
When does the Olumiant patent expire?
The last patent listed for Olumiant in the Orange Book expires November 30, 2032. 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.