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:	155
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
Assistance Publique - Hpitaux de Paris	PHASE2

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
Msn	OLUMIANT	baricitinib	TABLET;ORAL	217585-003	Aug 8, 2025	AB	RX	No	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018	AB	RX	Yes	No	8,158,616		Y	Y
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018	AB	RX	Yes	No	11,045,474

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
Honduras	2010001761
Dominican Republic	P2013000036
Croatia	P20161390

Supplementary Protection Certificates for BARICITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	C02288610/01	Switzerland		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66215 19.06.2017
2288610	17C0005	France		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170215
2288610	1790035-8	Sweden		PRODUCT NAME: BARICITINIB; REG. NO/DATE: EU/1/16/1170 20170215

BARICITINIB Market Analysis and Financial Projection

Last updated: February 6, 2026

What Are the Market Dynamics for BARICITINIB?

Baricitinib, marketed primarily as Olumiant by Eli Lilly, is a Janus kinase (JAK) inhibitor approved for rheumatoid arthritis (RA) and authorized for COVID-19 treatment in certain regions. Market dynamics are influenced by clinical efficacy, regulatory approvals, competition, and expanding indications.

Clinical and Regulatory Landscape

Baricitinib received FDA approval for RA in 2018, with additional indications extending to severe COVID-19 symptoms in 2022. Regulatory bodies in Europe, Japan, and other territories have similar approvals, broadening its geographic reach.

Competitive Environment

Baricitinib faces competition from other JAK inhibitors, including tofacitinib (Xeljanz), upadacitinib (Rinvoq), and filgotinib. These competitors influence pricing and market share dynamics. The drug's differentiation hinges on its safety profile, dosing convenience, and approval for COVID-19.

Market Adoption and Prescription Trends

In RA, baricitinib's market share depends on physician preferences, insurance coverage, and head-to-head performance against other biologics and JAK inhibitors. During the COVID-19 pandemic, emergency use authorizations boosted its visibility but waned as vaccines and other treatments became available.

Key Market Drivers

• Expansion into new indications such as atopic dermatitis or hair loss remains under exploration.
• The COVID-19 authorization creates a temporary revenue spike but is not sustainable long-term.
• Ongoing clinical trials could alter its therapeutic positioning.

Threats and Challenges

• Safety concerns regarding infections, thrombosis, and other adverse reactions could impact prescribing.
• Patent expirations potentially lead to biosimilar or generic competition, reducing revenue.
• Regulatory restrictions or withdrawal threats due to safety issues.

How Is the Financial Trajectory for BARICITINIB Shaping?

Revenue Performance

Eli Lilly reported that Olumiant generated approximately $500 million in worldwide net sales in 2022, with growth driven by COVID-19 applications and RA treatment expansion. The COVID-related sales declined significantly after the initial peak but still comprise a notable share.

Price and Market Share Dynamics

Pricing strategies vary across regions, with U.S. list prices around $5,000 per month for RA treatment, slightly lower in Europe due to negotiations. Competition has pressured price reductions, especially as biosimilars approach.

R&D and Investment Outlook

Eli Lilly continues to invest in clinical trials for new indications, including alopecia areata and atopic dermatitis, which could position baricitinib for additional revenue streams. Development costs for additional indications range from $300 million to $500 million per phase 3 trial.

Patent and Commercial Timing

The original patent expires in the U.S. in 2031, with some extensions possible. Patent cliffs threaten revenue from 2031 onward unless new formulations or indications are approved.

Financial Risks

• Regulatory setbacks or safety issues could trigger revenue declines.
• Intellectual property challenges or biosimilar entries could erode market share.
• Competitive products may gain approval faster, limiting market penetration.

Summary Table: Market and Financial Snapshot

Aspect	Data Points
2022 global sales	~$500 million
Major indications	Rheumatoid arthritis, COVID-19
Approved regions	U.S., Europe, Japan, others
Key competitors	Tofacitinib, Upadacitinib, Filgotinib
Patent expiration	2031 (U.S.), extensions possible
R&D investment (per trial)	$300-$500 million
Pricing per month (RA)	~$5,000 (U.S.)

Key Takeaways

• Market growth depends on expanding approved uses, competing products, and regional uptake.
• Revenue is vulnerable to safety concerns, patent cliffs, and biosimilar entries.
• Clinical trial pipeline and regulatory landscape shape future revenue trajectories.
• Pricing strategies need to adapt to competitive pressures and reimbursement negotiations.
• Continued investments signal Eli Lilly's commitment but increase financial risks if development delays or safety issues occur.

FAQs

1. What are the primary therapeutic uses of baricitinib?
It is mainly used for rheumatoid arthritis and authorized for COVID-19 in specific markets.

2. How does the competition influence baricitinib’s market share?
Competition from other JAK inhibitors limits pricing power and market penetration, especially as biosimilar options emerge.

3. When is patent protection for baricitinib expected to expire?
Patent expiration is projected for 2031 in the U.S., with possible extensions.

4. What potential new indications could impact its market?
Atopic dermatitis, alopecia areata, and other immune-mediated conditions under clinical evaluation could expand its commercial footprint.

5. How has COVID-19 affected baricitinib’s revenue?
It caused a spike during emergency usage, but long-term revenue impact depends on regional approvals and continued clinical demand.

References

[1] Eli Lilly. (2022). Annual report.
[2] FDA. (2022). Approval history for Olumiant.
[3] IQVIA. (2022). Pharmaceutical sales data.
[4] ClinicalTrials.gov. (2023). Baricitinib trials.