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Orange Book drug · Brand (NDA)

Olumiant

Baricitinib

RLDNDA 207924 3 strengths Eli Lilly And Co
Approved
May 31, 2018
Strengths
3
Listed patents
6
Applications
2

What does the FDA Orange Book show for Olumiant?

Olumiant contains Baricitinib and appears in 2 FDA Orange Book applications. NDA 207924 is the lead filing, with 3 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 207924

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Eli Lilly And Co

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
3

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AB

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
6

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0012MGTABLETORALPrescriptionAB
RLD
0021MGTABLETORALPrescriptionAB
RLD
0034MGTABLETORALPrescriptionAB
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Eli Lilly And Co

The Orange Book identifies this organization as the applicant responsible for NDA 207924.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

3 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

6 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 30, 2032. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 207924 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-207924

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

3 approved presentations · NDA 207924
TE ABRLD
Strength
2MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 3 mo ago

  2. Today

  3. Patent 8420629 expires

    Listed method-of-use patent (U-247) expiration.

    in 2 yr 8 mo

  4. Patent 11806555 expires

    Listed method-of-use patent (U-3500) expiration.

    in 5 yr 4 mo

  5. Patent 9737469 expires

    Listed method-of-use patent (U-3500) expiration.

    in 5 yr 4 mo

  6. Patent 8158616 expires

    Listed drug substance patent expiration.

    in 5 yr 11 mo

  7. Patent 11045474 expires

    Listed method-of-use patent (U-3372) expiration.

    in 6 yr 5 mo

  8. Patent 9089574 expires

    Listed method-of-use patent (U-3372) expiration.

    in 6 yr 5 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 8420629: 2029-03-10Patent 8420629Patent 11806555: 2031-11-02Patent 11806555Patent 9737469: 2031-11-02Patent 9737469Patent 8158616: 2032-05-31Patent 8158616Patent 11045474: 2032-11-30Patent 11045474Patent 9089574: 2032-11-30Patent 9089574
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BARICITINIB

Strength

2MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 207924

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8420629in 2 yr 8 mo
U-247
11806555in 5 yr 4 mo
U-3500
9737469in 5 yr 4 mo
U-3500
8158616in 5 yr 11 mo
SubstanceProduct
11045474in 6 yr 5 mo
U-3372
9089574in 6 yr 5 mo
U-3372

Other FDA applications for Olumiant

1 additional filing · 1 generic

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Olumiant, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 217585MsnAug 08, 20253ABPrescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Baricitinib family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Olumiant: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 207924 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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