BARICITINIB - Generic Drug Details

What are the generic drug sources for baricitinib and what is the scope of patent protection?

Baricitinib is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Eli Lilly And Co, and MSN, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for BARICITINIB

International Patents:	105
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	151
Patent Applications:	7,006
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BARICITINIB
What excipients (inactive ingredients) are in BARICITINIB?	BARICITINIB excipients list
DailyMed Link:	BARICITINIB at DailyMed

Recent Clinical Trials for BARICITINIB

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

Sponsor	Phase
ANRS, Emerging Infectious Diseases	PHASE2
Assistance Publique - Hôpitaux de Paris	PHASE3
Eli Lilly and Company	PHASE3

See all BARICITINIB clinical trials

Pharmacology for BARICITINIB

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BARICITINIB

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BARICITINIB

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 BARICITINIB

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	8,420,629
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022	AB	RX	Yes	Yes	8,158,616		Y	Y
Aurobindo Pharma Ltd	BARICITINIB	baricitinib	TABLET;ORAL	217542-002	Jul 22, 2024		DISCN	No	No
Msn	OLUMIANT	baricitinib	TABLET;ORAL	217585-003	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 BARICITINIB

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 BARICITINIB

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.)

Supplementary Protection Certificates for BARICITINIB

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

Market Dynamics and Financial Trajectory for BARICITINIB

Last updated: July 28, 2025

Introduction

Baricitinib, a Janus kinase (JAK) inhibitor developed by Eli Lilly and licensed for treatment of several autoimmune diseases, has emerged as a significant pharmaceutical asset amid expanding indications and competitive landscape shifts. Originally approved for rheumatoid arthritis (RA), its repositioning for COVID-19 treatment and potential expansion into other therapeutic domains have substantially influenced its market trajectory. Understanding the intricate market dynamics and financial prospects of baricitinib requires analyzing its current regulatory status, competitive environment, clinical pipeline, and broader healthcare trends.

Regulatory Landscape and Acceptance

Baricitinib received initial approval from the U.S. Food and Drug Administration (FDA) in 2018 for moderate to severe rheumatoid arthritis, positioning it as a key competitor within the JAK inhibitor class alongside tofacitinib and upadacitinib. The FDA later granted Emergency Use Authorization (EUA) for baricitinib in combination with remdesivir for COVID-19 patients requiring supplemental oxygen or ventilation, significantly elevating its visibility and sales during the pandemic (FDA, 2020 [1]).

European Medicines Agency (EMA) approved baricitinib for RA and later expanded indications, reinforcing its global footprint. However, the drug's acceptance faces regulatory hurdles in certain markets over safety concerns—particularly relating to thrombosis and infections, which have implications for its market access and pricing strategies (EMA, 2021 [2]).

Market Demand and Therapeutic Expansion

Autoimmune Diseases

The primary revenue source remains treatment of rheumatoid arthritis, where baricitinib competes with established biologics and other oral DMARDs. The global RA market is projected to reach USD 31 billion by 2025, with a CAGR of approximately 4% (Grand View Research, 2022 [3]). Baricitinib's ability to offer oral convenience and targeted immunosuppression positions it favorably, especially among patients seeking alternatives to injectable biologics.

COVID-19 Indications

The COVID-19 pandemic catalyzed immediate demand, with baricitinib positioned as a proposed therapy to mitigate cytokine storm effects. While pandemic-related sales spiked, the sustainability of COVID-19-specific revenues remains uncertain, contingent on evolving treatment protocols and viral epidemiology. As the pandemic wanes, the focus shifts toward integrating baricitinib into treatment algorithms for other inflammatory or infectious diseases (FDA, 2020 [1]).

Emerging and Investigational Uses

Ongoing clinical trials are exploring baricitinib's potential in dermatology (atopic dermatitis), hematology (cytoproliferative disorders), and oncology. Positive trial outcomes could diversify revenue streams, especially if label expansions are approved. However, this also heightens competition and regulatory risk.

Market Dynamics and Competitive Environment

Competitive Positioning

Baricitinib faces competition from other JAK inhibitors such as tofacitinib (Xeljanz) and upadacitinib (Rinvoq). Tofacitinib, approved since 2012, commands a sizable market share, but concerns over safety profile and administration route favor newer agents. Upadacitinib's higher selectivity and promising efficacy positions it as a direct rival with a comparable target demographic.

Pricing and Reimbursement

Pricing strategies for baricitinib align with high-cost biologics and targeted synthetic DMARDs, with list prices exceeding USD 50,000 per year in developed markets. Payer negotiations and formulary placements influence actual reimbursement and accessible patient populations. During the pandemic, supplemental funding and expedited approvals temporarily alleviated some barriers but long-term pricing remains under scrutiny amid rising healthcare costs and biosimilar threats.

Biosimilars and Patent Expiry

Patent expirations threaten to erode market share, particularly in key markets like the EU and the US. Eli Lilly has taken strategic measures, such as patent extensions and litigation, to prolong exclusivity. Nonetheless, biosimilars of structurally similar molecules could introduce pricing pressures within the next 5-7 years, impacting revenue forecasts.

Financial Trajectory and Revenue Outlook

Historical Sales Performance

Eli Lilly reported global sales of baricitinib at approximately USD 726 million in 2021, reflecting rapid growth driven largely by COVID-19 indications and RA sales (Eli Lilly Annual Report, 2022 [4]). The pandemic's peak significantly bolstered revenue figures, but post-pandemic scenarios highlight the need for diversification and sustained demand.

Forecasted Revenue Growth

Market analysts project that, with the upcoming expansion into additional indications and geographic markets, baricitinib's revenue could potentially surpass USD 1.2 billion annually by 2025 with a compound annual growth rate (CAGR) of nearly 15%. This estimate assumes approvals in major Asian markets and successful expansion into dermatological indications, alongside steady RA sales (GlobalData, 2022 [5]).

Risks and Opportunities

Key risks include regulatory delays, safety concerns impacting market acceptance, competitive pressures from newer agents, and patent challenges. Conversely, opportunities reside in clinical trial success, label expansions, and strategic partnerships for molecular innovation.

Market Trends Influencing the Trajectory

Shift Toward Oral Small Molecules

The pharmaceutical industry’s broader move toward oral small molecules over biologics supports baricitinib's positioning, as convenience-driven patient preference enhances adherence and market penetration.

Personalized Medicine and Precision Therapies

Advances in biomarker development could facilitate more targeted use of JAK inhibitors, enabling differentiated treatment strategies and specific market segments.

Pricing Pressures and Healthcare Policies

Global healthcare expenses and cost-containment policies influence pricing strategies. Industry players must optimize value-based pricing models to sustain margins.

Digital Health and Patient Engagement

Emerging digital health tools and remote monitoring could improve patient adherence and satisfaction, indirectly elevating the commercial viability of drugs like baricitinib.

Key Takeaways

• Market Position: Baricitinib maintains a strong position in RA therapy, bolstered temporarily by COVID-19 treatment indications, with significant growth prospects in expanding into dermatology and other inflammatory disorders.

• Revenue Outlook: With strategic label expansions and geographic penetration, revenues could exceed USD 1.2 billion annually by 2025, driven by increased adoption and competitive differentiation.

• Competitive Challenges: Facing fierce competition from established and emerging JAK inhibitors, alongside patent expirations, companies must navigate pricing pressures and safety concerns meticulously.

• Regulatory and Safety Risks: Safety profiles influence market acceptance; proactive risk management and robust post-market surveillance are essential to sustain revenue streams.

• Market Trends: The shift toward oral, targeted therapies, alongside personalized medicine, aligns with baricitinib's profile but necessitates continuous innovation and pipeline development.

Conclusion

Baricitinib's market dynamics reflect a complex interplay of regulatory approvals, competitive forces, and clinical advancements. Its financial trajectory hinges on successful pipeline expansion, strategic market positioning, and adaptation to healthcare policy shifts. While near-term growth remains promising, especially with ongoing clinical developments, long-term success depends on effectively mitigating safety concerns, patent challenges, and market competition.

---

FAQs

1. What are the primary therapeutic indications for baricitinib?
Baricitinib is primarily approved for rheumatoid arthritis and has received emergency authorization for COVID-19 treatment in combination with remdesivir. Ongoing trials are exploring its use in dermatology, hematology, and oncology.

2. How does the competitive landscape affect baricitinib's market share?
The presence of other JAK inhibitors like tofacitinib and upadacitinib intensifies competition, potentially impacting market share and pricing. Strategic differentiation and broadening indications are vital for sustained growth.

3. What factors could threaten the financial stability of baricitinib?
Patent expirations, safety concerns, regulatory delays, and biosimilar competition pose significant risks, potentially reducing revenues and market exclusivity.

4. How might COVID-19 impact future sales of baricitinib?
While initial pandemic-driven demand boosted sales, the decline in COVID-19 cases and treatment reliance may diminish revenues unless the drug secures solid positioning in other therapeutic areas.

5. What role does geographic expansion play in baricitinib's financial outlook?
Expanding into emerging markets, especially Asia, can significantly enhance revenues, provided regulatory hurdles and price negotiations are successfully managed.

---

References

[1] FDA. (2020). Emergency Use Authorization for Baricitinib.
[2] EMA. (2021). Market authorization for Baricitinib.
[3] Grand View Research. (2022). Rheumatoid Arthritis Market Size & Trends.
[4] Eli Lilly. (2022). Annual Report.
[5] GlobalData. (2022). Pharmaceutical Market Outlook.