FDA Orange Book · active-ingredient family
Baricitinib
Baricitinib is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OLUMIANT · NDA 207924
1
Brand (NDA)
2
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLUMIANTRLD×3 | ELI LILLY AND CO | NDA 207924 | AB | Oct 08, 2019 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLUMIANT×3 | MSN | ANDA 217585 | AB | Aug 08, 2025 | |
| BARICITINIB×2 | AUROBINDO PHARMA LTD | ANDA 217542 | — | Jul 22, 2024 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8420629 | Mar 10, 2029 | in 2 yr 9 mo | U-247 |
| 9737469 | Nov 02, 2031 | in 5 yr 5 mo | U-3500 |
| 11806555 | Nov 02, 2031 | in 5 yr 5 mo | U-3500 |
| 8158616 | May 31, 2032 | in 6 yr | SubstanceProduct |
| 11045474 | Nov 30, 2032 | in 6 yr 7 mo | U-3372 |
| 9089574 | Nov 30, 2032 | in 6 yr 7 mo | U-3372 |
Baricitinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
