OLUMIANT Drug Patent Profile

When do Olumiant patents expire, and when can generic versions of Olumiant launch?

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:	4,101
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
Vanderbilt University Medical Center	Phase 2
University of Minnesota	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
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	207924-001	May 31, 2018	AB	RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022	AB	RX	Yes	Yes

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	102027394
Croatia	P20161390
Lithuania	C2288610
Portugal	2288610
Mexico	2014006479	INHIBIDORES ANTIVIRALES DE LA JANUS CINASA UTILES EN EL TRATAMIENTO O PREVENCION DE INFECCIONES RETROVIRALES Y OTRAS INFECCIONES VIRALES. (ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS.)
Japan	5948337
China	104185420	Antiviral jak inhibitors useful in treating or preventing retroviral and other viral infections

Supplementary Protection Certificates for OLUMIANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	1790035-8	Sweden		PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215
2288610	PA2017023	Lithuania		PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	2017C/025	Belgium		PRODUCT NAME: OLUMIANT - BARICITINIB; AUTHORISATION NUMBER AND DATE: EU/1/16/1170 20170215
2288610	CA 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	PA2017023,C2288610	Lithuania		PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	2017/032	Ireland		PRODUCT NAME: BARACITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	132017000078559	Italy		PRODUCT NAME: BARICITINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(OLUMIANT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1170, 20170215

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OLUMIANT

Last updated: July 27, 2025

Introduction

OLUMIANT (baricitinib) emerges as a significant player in the burgeoning landscape of targeted immunomodulatory therapies. Developed initially by Eli Lilly and Company, OLUMIANT is a Janus kinase (JAK) inhibitor; it has garnered attention due to its therapeutic efficacy in rheumatoid arthritis and its expanded potential in treating COVID-19-related complications. Understanding the market dynamics and financial trajectory of OLUMIANT requires an examination of its clinical positioning, competitive landscape, regulatory environment, and commercialization strategies.

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Clinical Positioning and Therapeutic Indications

OLUMIANT primarily targets moderate to severe rheumatoid arthritis (RA), a chronic autoimmune disorder affecting approximately 1.3 million Americans alone [1]. Its mechanism—selective inhibition of JAK1 and JAK2—disrupts inflammatory pathways, offering an alternative to biologic disease-modifying antirheumatic drugs (DMARDs).

More recently, its emergency authorization for COVID-19 indications—particularly in hospitalized patients with severe illness—expanded its potential market. The FDA granted Emergency Use Authorization (EUA) for OLUMIANT in combination with remdesivir in COVID-19 treatment, leveraging its immunomodulatory properties [2]. While the COVID-19 indication is temporary, it enhances the drug's visibility and profitability.

Impact on Market Positioning

The well-established efficacy in RA drives consistent revenues, whereas expansion into COVID-19 complicates the long-term financial forecast due to regulatory uncertainty and potential reimbursement challenges. The drug’s repositioning underscores the importance of flexible therapeutic applications in pharmaceutical growth strategies.

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Market Dynamics

1. Competitive Landscape

OLUMIANT operates within a highly competitive environment dominated by biologic agents (e.g., adalimumab, etanercept) and other JAK inhibitors such as Pfizer’s Xeljanz (tofacitinib) and AbbVie's Rinvoq (upadacitinib). The competitive edge hinges on factors like efficacy, safety profiles, administration routes, patent exclusivity, and pricing.

Eli Lilly's strategic positioning emphasizes its moderate dosing regimen—once daily—which offers convenience advantages. However, safety concerns—such as increased infection risk associated with JAK inhibitors—pose challenges for physician adoption.

2. Regulatory Approvals & Reimbursement Policies

Regulatory approval trends influence OLUMIANT’s market penetration. Post-approval, securing insurance reimbursement determines prescribing patterns. Notably, the European Medicines Agency (EMA) approved OLUMIANT for RA in 2017, with national health systems incentivizing uptake through reimbursement agreements.

The COVID-19 indication catalyzed regulatory acceleration but also introduced scrutiny, especially regarding patient safety and post-market surveillance.

3. Pricing Strategies and Market Penetration

Pricing remains pivotal. OLUMIANT is positioned as a competitive biologic alternative, typically priced lower than some biologics yet higher than small-molecule DMARDs. Lilly’s aggressive pricing and patient assistance programs aim to expand accessibility and market share.

Volume growth depends heavily on prescription patterns, physician adoption, and penned agreements with payers. As of Q2 2023, OLUMIANT’s US sales reached approximately $250 million annually, indicating steady growth but facing saturation in the RA segment [3].

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Financial Trajectory

1. Revenue Trends

In 2022, OLUMIANT’s global revenues increased by approximately 18% year-over-year, driven predominantly by US sales growth in RA and increased utilization for COVID-19-related indications. Despite competition, Lilly’s strategic marketing programs and clinical data dissemination have supported revenue expansion.

The COVID-19 pandemic temporarily boosted sales due to its emergency use, but as the pandemic phases out, future revenue depends on sustained RA sales and any new indications.

2. Pipeline and Market Expansion

Expansion into other autoimmune diseases, such as atopic dermatitis and ulcerative colitis, is under clinical evaluation. Positive trial data could diversify revenue streams, mitigate RA market saturation, and bolster the drug’s long-term financial outlook [4].

Lilly has also considered biosimilars’ impact, which could erode profit margins over time, emphasizing the importance of patent protections and future pipeline development.

3. Price and Cost Dynamics

Cost containment remains vital due to competitive pressures and payer negotiations. Lilly’s investments in pharmacovigilance and post-market studies to reinforce safety profiles support pricing strategies. Cost of goods sold (COGS), largely driven by manufacturing and distribution, is expected to stabilize as production scales.

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Market Challenges and Opportunities

Challenges:

• Safety Concerns: Reports of increased thromboembolic events and infections necessitate vigilant post-market monitoring and could hinder broader adoption.
• Regulatory Uncertainty: Potential restrictions or label updates following safety reviews may constrain usage.
• Competition: Biologics and newer JAK inhibitors with improved safety profiles threaten OLUMIANT’s market share.
• Patent and Biosimilar Threat: Patent expirations could lead to biosimilar competition, impacting future revenues.

Opportunities:

• Expansion into New Indications: Promising results in alopecia areata and other autoimmune conditions suggest potential for revenue diversification.
• COVID-19 Market Sustainment: Continued use in specific patient subsets or as part of combination therapies may sustain profitability.
• Strategic Partnerships: Collaborations with healthcare providers and formulary agreements could expand access.

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Conclusion

OLUMIANT’s market dynamics are characterized by its strong position within RA, competitive pressures, and evolving regulatory landscapes. Its financial trajectory hinges on maintaining clinical competitiveness, expanding indications, and navigating biosimilar and safety challenges. While current revenue growth reflects strategic success, long-term profitability depends on pipeline expansion and market adaptation.

Key Takeaways

• OLUMIANT benefits from a robust RA market with opportunities to broaden its use in other autoimmune diseases.
• Competition from biologics and other JAK inhibitors remains intense, necessitating strategic differentiation.
• Regulatory developments, especially safety profile updates, are critical in shaping its market accessibility.
• The COVID-19 indication added short-term revenue but introduces uncertainty for long-term growth related to pandemic-driven demand.
• Pipeline development and patent protections are vital to sustaining growth and warding off biosimilar threats.

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FAQs

1. How does OLUMIANT’s efficacy compare to other JAK inhibitors?
OLUMIANT has demonstrated comparable efficacy to other JAK inhibitors like tofacitinib and upadacitinib in RA clinical trials, with some data suggesting a favorable safety profile in specific populations. Direct head-to-head comparisons, however, are limited.

2. What are the major safety concerns associated with OLUMIANT?
The primary safety issues include increased risks of infections, thromboembolic events, and potential malignancies. These concerns have led to warnings and post-market surveillance commitments.

3. Will OLUMIANT continue to benefit from COVID-19-related usage?
While the emergency authorization boosted short-term sales, its long-term benefit is uncertain. Future applications depend on ongoing research and regulatory decisions regarding COVID-19 treatment protocols.

4. How does patent protection influence OLUMIANT’s market longevity?
Patent exclusivity shields OLUMIANT from biosimilar competition temporarily. Patent expiry (~2028–2030) could open the market to biosimilars, impacting revenue unless new indications or formulations extend its lifecycle.

5. What strategic initiatives can Lilly pursue to maximize OLUMIANT’s market impact?
Lilly can focus on expanding indications, enhancing safety profiles through post-market studies, establishing strong payer relationships, and innovating formulations or delivery methods to improve patient adherence.

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References

[1] CDC. Rheumatoid Arthritis Statistics. Centers for Disease Control and Prevention. 2021.
[2] FDA. EUA for OLUMIANT in COVID-19. U.S. Food and Drug Administration. 2020.
[3] Eli Lilly. Quarterly Financial Reports. 2023.
[4] ClinicalTrials.gov. Ongoing Trials for OLUMIANT in Various Autoimmune Diseases. 2023.