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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

68 trials from ClinicalTrials.gov — 4 recruiting, 2 active, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis NCT04088409	Phase 3	Active	Eli Lilly and Company	30	2019-10-16 → 2028-07
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis NCT03952559	Phase 3	Active	Eli Lilly and Company	516	2019-05-24 → 2026-05
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
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
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response NCT03414502	Phase 3	Recruiting	University of Nebraska	400	2007-12-10 → 2029-03
Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes NCT01724580	—	APPROVED_FOR_MARKETING	Eli Lilly and Company	—	—
A Study in Moderate to Severe Rheumatoid Arthritis NCT01710358	Phase 3	Completed	Eli Lilly and Company	1,307	2012-10 → 2015-09
A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy NCT01185353	Phase 2	Completed	Eli Lilly and Company	301	2010-10 → 2014-03
A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis NCT01490632	Phase 2	Completed	Eli Lilly and Company	271	2011-12 → 2014-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$184.66

per ea

Lowest NADAC/Unit

$92.26

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00002447930OLUMIANT 4 MG TABLET	$184.66	EA	Brand	—	2026-01-01
00002418230OLUMIANT 2 MG TABLET	$92.26	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$2024.52

Highest Price

$4728.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-4479-30OLUMIANT 4MG TAB	$4728.20	FSS	Eli Lilly & Company	09/28/2030
00002-4479-30OLUMIANT 4MG TAB	$4054.30	Big4	Eli Lilly & Company	09/28/2030
00002-4182-30OLUMIANT 2MG TAB	$2364.10	FSS	Eli Lilly & Company	09/28/2030
00002-4182-30OLUMIANT 2MG TAB	$2024.52	Big4	Eli Lilly & Company	09/28/2030
00002-4732-30OLUMIANT 1MG TAB	$2364.10	FSS	Eli Lilly & Company	09/28/2030
00002-4732-30OLUMIANT 1MG TAB	$2038.13	Big4	Eli Lilly & Company	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Olumiant (2024)

Total Spending

$35.4M

Total Claims

9,553

Beneficiaries

1,609

Avg Cost/Unit

$104.76

Spending Trend

$14.8M(2019)→$18.7M(2020)→$19.3M(2021)→$21.1M(2022)→$28.3M(2023)→$35.4M(2024)

YoY Change:+3.0%

5yr CAGR:+8.0%

Source: CMS Medicare Part D Spending by Drug (2024). 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

7 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2026	SUPPL -11	View Letter (PDF)
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) · 5 use codes

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