FDA Orange Book · active-ingredient family
Baricitinib
Baricitinib: 1 brand, 2 generics; first approved May 31, 2018; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
6
Next patent expiry
Mar 10, 2029
in 2 yr 7 mo
Brand (NDA) products
Originator applications
- OLUMIANTRLDELI LILLY AND CONDA 20792420193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- MSNANDA 21758520253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - BARICITINIBAUROBINDO PHARMA LTDANDA 21754220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8420629 | in 2 yr 7 mo | U-247 | |
| 9737469 | in 5 yr 4 mo | U-3500 | |
| 11806555 | in 5 yr 4 mo | U-3500 | |
| 8158616 | in 5 yr 11 mo | SubstanceProduct | |
| 11045474 | in 6 yr 5 mo | U-3372 | |
| 9089574 | in 6 yr 5 mo | U-3372 |
Approval history
FDA approval span
First approval
8 yr 4 mo ago
Most recent approval
1 yr ago
Approvals span 2018–2025 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Baricitinib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
