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OLUMIANT

NDA

BARICITINIB | N207924 | ELI LILLY AND CO

3 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2027

2028

2029

2030

2031

2032

2033

Today

May. 31, 2032

Mar. 10, 2029

Nov. 30, 2032

Nov. 2, 2031

Nov. 30, 2032

Nov. 2, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Eli Lilly and Company et al v. MSN Laboratories Private Limited et al 1:2023cv01277 1 patentANDA 217585baricitinib	D. Del.	2023-11-08	Terminated 2024-05-17	—
Eli Lilly and Company et al v. MSN Laboratories Private Limited 1:2022cv01114 2 patentsANDA 217542baricitinib	D. Del.	2022-08-24	Terminated 2024-05-17	—
Eli Lilly and Company et al v. MSN Laboratories Private Limited et al 1:2022cv01115 2 patentsANDA 217585baricitinib	D. Del.	2022-08-24	Terminated 2024-05-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov — 7 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
TPO-RA Plus Baricitinib vs. TPO-RA for ITP NCT07669675	Phase 2	Not Yet Recruiting	Peking University People's Hospital	100	2026-07-01 → 2028-08-31
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults NCT07222137	Phase 3	Recruiting	Eli Lilly and Company	150	2026-01-12 → 2031-07
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)NCT04088396	Phase 3	Recruiting	Eli Lilly and Company	58	2020-02-12 → 2026-09
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis NCT07262983	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	20	2026-07-07 → 2030-10-01
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)NCT07222332	Phase 3	Recruiting	Eli Lilly and Company	300	2026-02-05 → 2028-07
Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement NCT06923072	Phase 2	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	12	2026-02-18 → 2030-12-15
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis NCT03773965	Phase 3	Recruiting	Eli Lilly and Company	190	2019-04-05 → 2031-07
Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial NCT05189106	Phase 1/2	Completed	Massachusetts General Hospital	17	2022-12-05 → 2025-06-20
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis NCT03915964	Phase 4	Completed	Eli Lilly and Company	2,659	2019-04-25 → 2025-05-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Olumiant (2023)

Total Spending

$28.3M

Total Claims

7,882

Beneficiaries

1,389

Avg Cost/Unit

$101.66

Spending Trend

$14.8M(2019)→$18.7M(2020)→$19.3M(2021)→$21.1M(2022)→$28.3M(2023)

YoY Change:+15.9%

5yr CAGR:+8.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDBARICITINIB

DMF 353402020

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDBARICITINIB

DMF 360302021

APITORIA PHARMA PRIVATE LTDBARICITINIB

DMF 365982021

WISDOM PHARMACEUTICAL CO LTDBARICITINIB

DMF 367322022

NANJING LIBRAVO PHARMACEUTICAL CO LTDBARICITINIB

DMF 372442022

ZAKLADY FARMACEUTYCZNE POLPHARMA SABARICITINIB

DMF 395622024

TONGSHENG PHARMACEUTICAL (JINGMEN) CO LTDBARICITINIB INTERMEDIATE 1

DMF 433062025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2022	SUPPL -7	View Letter (PDF)
May 11, 2022	SUPPL -6	View Letter (PDF)
Dec 7, 2021	SUPPL -4	View Letter (PDF)
Jul 9, 2020	SUPPL -2	View Letter (PDF)
Oct 10, 2019	SUPPL -1	View Letter (PDF)
Jun 1, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG

RLDAB

6 patents0 exclusivities▴

TABLET;ORAL | Approved: May 31, 2018

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8158616	May 31, 2032	—	Yes	Yes	—	—
8420629	Mar 10, 2029	—	—	—		—
9089574	Nov 30, 2032	—	—	—		—
9737469	Nov 2, 2031	—	—	—		—
11045474	Nov 30, 2032	—	—	—		—
11806555	Nov 2, 2031	—	—	—		—

#002 — 1MG

RLDAB

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 8, 2019

#003 — 4MG

RLDAB

5 patents0 exclusivities▾

TABLET;ORAL | Approved: May 10, 2022