OLUMIANT Drug Patent Profile

When do Olumiant patents expire, and what generic alternatives are available?

Olumiant is a drug marketed by Eli Lilly And Co and MSN and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and five patent family members in forty-four countries.

The generic ingredient in OLUMIANT is baricitinib. One supplier is listed for this compound. Additional details are available on the baricitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Olumiant

Olumiant was eligible for patent challenges on May 31, 2022.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OLUMIANT

International Patents:	105
US Patents:	6
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	16
Patent Applications:	3,173
Drug Prices:	Drug price information for OLUMIANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLUMIANT
What excipients (inactive ingredients) are in OLUMIANT?	OLUMIANT excipients list
DailyMed Link:	OLUMIANT at DailyMed

See drug prices for OLUMIANT

Recent Clinical Trials for OLUMIANT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Emory University	Phase 2
Vanderbilt University Medical Center	Phase 2

See all OLUMIANT clinical trials

Pharmacology for OLUMIANT

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for OLUMIANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLUMIANT	Tablets	baricitinib	4 mg	207924	1	2023-10-03
OLUMIANT	Tablets	baricitinib	1 mg and 2 mg	207924	2	2022-05-31

US Patents and Regulatory Information for OLUMIANT

OLUMIANT is protected by six US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019	AB	RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022	AB	RX	Yes	Yes
Msn	OLUMIANT	baricitinib	TABLET;ORAL	217585-001	Aug 8, 2025	AB	RX	No	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019	AB	RX	Yes	No

EU/EMA Drug Approvals for OLUMIANT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Olumiant	baricitinib	EMEA/H/C/004085Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),- Enthesitis related arthritis, and- Juvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate.	Authorised	no	no	no	2017-02-13

International Patents for OLUMIANT

When does loss-of-exclusivity occur for OLUMIANT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Mexico

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OLUMIANT around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102135601
European Patent Office	4556010
Japan	5948337
Japan	2016196481

Supplementary Protection Certificates for OLUMIANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	655	Finland
2288610	SPC/GB17/045	United Kingdom		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/16/1170/001(NI) 20170215; UK EU/1/16/1170/002(NI) 20170215; UK EU/1/16/1170/003(NI) 20170215; UK EU/1/16/1170/004(NI) 20170215; UK EU/1/16/1170/005(NI) 20170215; UK EU/1/16/1170/006(NI) 20170215; UK EU/1/16/1170/013(NI) 20170215; UK EU/1/16/1170/014(NI) 20170215; UK EU/1/16/1170/015(NI) 20170215; UK EU/1/16/1170/016(NI) 20170215; UK PLGB 14895/0255 20170215; UK PLGB 14895/0256 20170215; UK EU/1/16/1170/007(NI) 20170215; UK EU/1/16/1170/008(NI) 20170215; UK EU/1/16/1170/009(NI) 20170215; UK EU/1/16/1170/010(NI) 20170215; UK EU/1/16/1170/011(NI) 20170215; UK EU/1/16/1170/012(NI) 20170215
2288610	2017C/025	Belgium		PRODUCT NAME: OLUMIANT - BARICITINIB; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215
2288610	17C0005	France		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170215

Market Dynamics and Financial Trajectory for Olumiant (Baricitinib): A Comprehensive Analysis

Last updated: December 30, 2025

Executive Summary

Olumiant (baricitinib), developed by Eli Lilly and Company, is a JAK1/JAK2 inhibitor primarily approved for the treatment of rheumatoid arthritis (RA) and recently authorized for COVID-19 under Emergency Use Authorization (EUA) in certain jurisdictions. This report examines the evolving market landscape, competitive positioning, regulatory environment, and financial outlook, emphasizing key drivers and risks that influence its trajectory over the next five years.

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What is Olumiant (Baricitinib)?

Product Details	Description
Generic Name	Baricitinib
Brand Name	Olumiant
Therapeutic Class	Janus kinase (JAK) inhibitor
Primary Indications	Rheumatoid arthritis, COVID-19 (EUA), atopic dermatitis (investigational)
Approval Dates	FDA: May 2018; EMA: January 2019; EUA for COVID-19: November 2020

Olumiant is a selective JAK1/JAK2 inhibitor, disrupting cytokine signaling pathways involved in immune response. Its initial success hinges on its oral administration, favorable efficacy profile, and manageable safety profile.

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What Are the Market Drivers for Olumiant?

1. Expanding Rheumatoid Arthritis (RA) Market

Attribute	Details
Global RA Market Size	~$25 billion (2022) and expected to grow at CAGR of 4.5% (2022-2027) [1]
Major Players	Humira (AbbVie), Enbrel (Amgen), Xeljanz (Pfizer), Olumiant
Market Penetration	Approximately 3-5% of RA patients on JAK inhibitors; large unmet need persists

2. COVID-19 Therapeutic Use

Attribute	Details
EUA in US	Granted Nov 2020 for hospitalized COVID-19 patients requiring oxygen or ventilation [2]
Market Size	COVID-19 treatments estimated at $100 billion globally (2020-2022) [3]
Relevance	Rapid adoption during pandemic, uncertain long-term use as vaccines and other treatments evolve

3. Evolving Treatment Paradigms & Pipeline Expansion

Indicator	Impact
Emerging Indications	Atopic dermatitis, alopecia areata, inflammatory bowel disease (clinical trials ongoing)
Combination Therapies	Potential synergies with biologics or other small molecules

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What Are the Key Market Barriers for Olumiant?

Barrier	Impact & Implication
Safety Concerns	Increased infection risk, thrombosis, malignancies may limit adoption [4]
Competitive Landscape	Dominance of established biologics and emerging oral JAK inhibitors like Xeljanz and Rinvoq
Regulatory & Pricing Pressures	Cost-effectiveness debates, reimbursement hurdles, especially in Europe

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How Is the Regulatory Environment Shaping Olumiant’s Market?

1. Regulatory Approvals & Labeling

Region	Status	Key Notes
United States	Approved (2018)	Indicated for RA; EUA for COVID-19; ongoing label discussions
European Union	Approved (2019)	Similar indications with cautious safety labeling
Japan	Approved (2019)	License expansion for different RA patient populations

2. Post-Marketing Surveillance and Labeling Adjustments

• Increased safety-related updates have limited initial prescribing.
• Regulatory bodies like EMA and FDA continually assess risk-benefit profiles as new data emerges.

3. Off-Label & Expanded Use Regulations

• Limited by safety advisories but potential for broader indications in inflammatory conditions.

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What Is the Financial Outlook for Olumiant?

Metrics / Projections	Current Figures (2022)	Forecast (2028)
Global Revenue	~$400 million	~$2.0 billion (estimating growth driven by RA and COVID-19 uses)
Market Share in RA	Approx. 8% (2022)	15-20% in targeted populations
EUA COVID-19 Sales	Contributed ~$100 million in 2021	Declining post-pandemic; resurgence possible if COVID-19 wave resurges
Pricing	~$5,500 per year (US)	Stable, with potential discounts in emerging markets

1. Revenue Drivers

• Growing prescription volume driven by unmet needs in RA and expanding indications.
• Market penetration increases with additional formulations and pivotal trial success.

2. Key Revenue Risks

• Post-pandemic decline in COVID-19 indications.
• Impact of safety warnings and clinical trial failures.
• Competition from biosimilars and oral JAK inhibitors (e.g., Xeljanz, Rinvoq).

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How Does Olumiant Compare with Competitors?

Criteria	Olumiant	Xeljanz (Pfizer)	Rinvoq (AbbVie)	Upadacitinib (AbbVie)
Approval Year	2018	2012	2019	2019
Targets	JAK1/JAK2	JAK1/3	JAK1	JAK1
Indications	RA, COVID-19	RA, psoriatic arthritis	RA, atopic dermatitis	RA, psoriatic arthritis
Pricing (US)	~$5,500/year	~$4,600/year	~$43,000/year (Rinvoq)	~$48,000/year
Efficacy	Moderate	High	High	High

Note: Rinvoq and Upadacitinib tend to have higher efficacy but also higher safety concerns which influence market share and pricing.

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What Are the Economic and Strategic Opportunities for 2023–2028?

Expansion of Indications

• Atopic dermatitis, alopecia areata, and inflammatory bowel disease candidates in late-stage trials.
• COVID-19 re-emergence if variants cause surges.

Manufacturing & Supply Chain Optimization

• Scaling production to meet increased demand.
• Cost reduction and access improvements in lower-income markets.

Partnerships & Licensing

• Collaborations with regional distributors.
• Co-developments in emerging indications.

Digital & Real-World Evidence Initiatives

• Use of AI and real-world data to demonstrate safety and efficacy.
• Enhancing payer negotiations through health economics data.

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What Are the Potential Risks to Olumiant’s Financial Trajectory?

Risk Factors	Impact
Safety Profile	New adverse event signals could restrict use
Competitive Dynamics	Market share erosion due to newer, more efficacious drugs
Regulatory Scrutiny	Label restrictions limiting prescribing flexibility
Market Saturation	Limited growth in mature RA markets

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Summary of Market and Financial Projections (2023–2028)

Aspect	2023	2025	2028
Market Penetration in RA	8%	12%	20%
Total Revenue (USD billion)	~$0.6	~$1.2	~$2.0
COVID-19 Revenue Contribution	Declining	Minimal	Minimal
Pipeline Approval Impact	Small	Moderate	Significant

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Key Takeaways

• Olumiant’s initial success in RA positions it well within the competitive oral JAK inhibitor segment.
• COVID-19 accelerated its market entry but offers diminishing revenue prospects amid pandemic waning.
• Safety concerns necessitate vigilant pharmacovigilance and may influence long-term sales.
• Pipeline expansion and label broadening could double revenues by 2028.
• Competitors with higher efficacy or safety profiles, as well as biosimilar entry, pose risks.
• Strategic partnerships, cost management, and real-world evidence will be crucial for sustained growth.

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FAQs

1. What are the primary drivers affecting Olumiant’s market growth?

Market expansion in RA treatment, new indications, pandemic-related revenue, and positioning against competitors are key drivers.

2. How does Olumiant compare to other JAK inhibitors?

Olumiant has similar efficacy to Rinvoq and Upadacitinib but faces safety and pricing challenges that influence prescriber preference.

3. What regulatory challenges could impact Olumiant’s sales?

Safety warnings, label restrictions, and evolving post-marketing requirements could limit prescriptions and reimbursement.

4. Which markets present the greatest growth opportunities?

Emerging markets like China, India, and Southeast Asia, along with expanded indications in North America and Europe, offer long-term potential.

5. What strategies can Eli Lilly implement to maximize Olumiant’s potential?

Investing in pipeline development, expanding indications through clinical trials, optimizing manufacturing, and strategic licensing are essential.

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References

1. Global Rheumatoid Arthritis Market Size & Trends (2022-2027) – MarketResearch.com.
2. FDA Emergency Use Authorization for Olumiant (2020) – FDA.gov.
3. Pharmaceutical Industry COVID-19 Revenue Analysis (2020-2022) – IQVIA.
4. Safety Profile and Post-Marketing Data for Baricitinib – EMA & FDA Safety Reports.

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This comprehensive review underscores that Olumiant’s market trajectory will depend on strategic clinical, regulatory, and commercial maneuvers amidst the competitive landscape. Its success hinges on leveraging pipeline potential while managing safety and market share challenges.