Baricitinib - Generic Drug Details

What are the generic 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 and Eli Lilly And Co, and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for baricitinib

International Patents:	103
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	123
Patent Applications:	5,176
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
University of North Carolina, Chapel Hill	Phase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 2
Healthcare Pharmaceuticals	Phase 2

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	207924-003	May 10, 2022		RX	Yes	Yes
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	9,737,469
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No	9,737,469
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No	9,089,574
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No	8,420,629

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/004085 Rheumatoid 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
Poland	2830662
Croatia	P20191548
Colombia	6290658	DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JACK
European Patent Office	2830662	MÉTHODES DE TRAITEMENT DE TROUBLES SE CARACTÉRISANT PAR LA PERTE DES CHEVEUX (METHODS FOR TREATING HAIR LOSS DISORDERS)
World Intellectual Property Organization (WIPO)	2009114512

Supplementary Protection Certificates for baricitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	2017033	Norway		PRODUCT NAME: BARICITINIB OG FARMASOEYTISK; REG. NO/DATE: EU/1/16/1170 20170222
2288610	CA 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	122017000045	Germany		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	C02288610/01	Switzerland		PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66215 19.06.2017
2288610	300886	Netherlands		PRODUCT NAME: BARICITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1170 20170215

Market Dynamics and Financial Trajectory of Baricitinib

Introduction to Baricitinib

Baricitinib, a selective and reversible Janus kinase (JAK) inhibitor, has emerged as a significant player in the treatment of various autoimmune diseases. Initially developed to treat rheumatoid arthritis (RA), its applications have expanded to include systemic lupus erythematosus, atopic dermatitis, and even severe COVID-19 cases[3,.

Market Growth and Projections

The baricitinib market is experiencing robust growth, driven by several key factors:

• Compound Annual Growth Rate (CAGR): The global baricitinib market is projected to grow at a CAGR of around 15% to 17% over the forecast period. By 2026, the market is expected to reach approximately $4.2 billion, and by 2031, it is anticipated to reach $17.48 billion[3][5].
• Expanding Indications: The drug's efficacy in treating multiple autoimmune conditions, including rheumatoid arthritis, atopic dermatitis, and severe COVID-19, is a major driver of market growth. Ongoing clinical trials exploring its effectiveness in other autoimmune diseases such as lupus and psoriatic arthritis further enhance its market potential[3][5].

Key Drivers of Market Growth

Several factors are contributing to the rapid growth of the baricitinib market:

• Rising Prevalence of Autoimmune Diseases: The increasing incidence of rheumatoid arthritis and other autoimmune diseases globally is a significant driver. The rise in healthcare expenditure and advancements in the biotechnology sector also play crucial roles[1][3].
• Clinical Trials and Approvals: The drug has received approvals from various regulatory bodies, including the FDA, European Commission, and Japanese Ministry of Health, Labor and Welfare. These approvals, along with ongoing clinical trials, have bolstered its market position[4][5].
• Cost-Effectiveness: Studies have shown that baricitinib is a cost-effective option compared to other disease-modifying antirheumatic drugs (DMARDs). It has been found to save commercial payers significant amounts over a two-year period, making it an attractive choice for healthcare providers[2].

Geographical Market Analysis

The baricitinib market is geographically diverse, with different regions contributing to its growth:

• North America: This region dominates the market due to its well-developed healthcare system and high adoption rates of advanced therapies[1].
• Asia-Pacific: This region is expected to witness high growth due to its large population and increasing healthcare expenditure. Countries like Japan, China, and India are key contributors to this growth[1][3].

Distribution Channels and End-Users

The market is segmented based on distribution channels and end-users:

• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies are the primary distribution channels. The convenience and accessibility offered by these channels contribute to the market's growth[1].
• End-Users: Hospitals, homecare, specialty clinics, and ambulatory surgical centers are the main end-users. The increasing demand from these sectors is driven by the drug's efficacy and the expanding range of indications[1].

Financial Trajectory

The financial trajectory of baricitinib is promising, with several key financial indicators:

• Market Size: The market size was valued at $5 billion in 2023 and is expected to reach $17.48 billion by 2031, growing at a CAGR of 17% from 2024 to 2031[5].
• Revenue Streams: The drug generates revenue through its sales in various therapeutic areas. The expansion into new indications and the introduction of new formulations are expected to create new revenue streams[3][5].
• Cost Savings: Adding baricitinib to formularies has been shown to save commercial payers significant amounts. For instance, it can save $169,742 for second-line therapy and $135,471 for third-line therapy over a two-year period[2].

Investment Opportunities

The baricitinib market offers substantial investment opportunities:

• Research and Development: Supporting ongoing research and development in new therapeutic areas is a lucrative investment opportunity. The drug's adaptability and potential in treating various autoimmune diseases make it an attractive investment target[3][5].
• Strategic Partnerships: Collaborations between pharmaceutical companies, such as the partnership between Eli Lilly and Company and Incyte Corporation, are crucial for the development and commercialization of baricitinib. These partnerships can drive innovation and market growth[4].

Challenges and Limitations

Despite the promising market dynamics, there are some challenges and limitations:

• Competition from Other Drugs: The availability of various classes of drugs can obstruct market growth. Low awareness among people about baricitinib is also a projected challenge[1].
• Regulatory and Safety Concerns: The need for additional clinical data to determine the most appropriate doses and characterize safety concerns has been a regulatory hurdle. However, ongoing safety surveillance studies have not demonstrated any new safety signals[4].

Recent Innovations

Recent innovations are enhancing the market for baricitinib:

• New Formulations and Delivery Methods: Developments in drug formulation and administration are improving the drug's efficacy and patient compliance. New dosing schedules and enhanced bioavailability are contributing to its growing popularity[3][5].
• Combination Therapies: The introduction of combination therapies that incorporate baricitinib with other agents is optimizing treatment outcomes and expanding its therapeutic applications[3].

Patient Epidemiology and Cost Analysis

• Patient Epidemiology: The rise in prevalence of rheumatoid arthritis and other autoimmune diseases is driving the demand for baricitinib. Patient epidemiology analysis helps in forecasting the market scenario for individual countries based on disease epidemiology and demographics[1].
• Cost Analysis: Studies have shown that baricitinib is a cost-effective option with comparable efficacy to other DMARDs. The cost per additional responder for baricitinib is substantially lower than other treatments, making it a favorable choice for healthcare providers[2].

Key Takeaways

• Rapid Market Growth: The baricitinib market is growing rapidly, driven by expanding indications and increasing global demand.
• Cost-Effectiveness: Baricitinib is a cost-effective option compared to other DMARDs, offering significant cost savings for healthcare providers.
• Investment Opportunities: The market offers substantial investment opportunities in research and development, new therapeutic areas, and strategic partnerships.
• Geographical Diversity: The market is geographically diverse, with North America and Asia-Pacific being key regions.
• Innovations: Recent innovations in drug formulation and administration are enhancing the drug's efficacy and patient compliance.

FAQs

Q: What is the projected market size of baricitinib by 2031? A: The global baricitinib market is expected to reach approximately $17.48 billion by 2031[5].

Q: What are the primary therapeutic areas for baricitinib? A: Baricitinib is primarily used to treat rheumatoid arthritis, systemic lupus erythematosus, atopic dermatitis, and severe COVID-19 cases[3].

Q: How does baricitinib compare to other DMARDs in terms of cost-effectiveness? A: Baricitinib is a less expensive option compared to other DMARDs, offering significant cost savings for healthcare providers over a two-year period[2].

Q: What are the key drivers of the baricitinib market growth? A: The key drivers include the rising prevalence of autoimmune diseases, clinical trials and approvals, and cost-effectiveness of the drug[1][3].

Q: Which regions are expected to witness high growth in the baricitinib market? A: North America and Asia-Pacific are expected to be key regions driving the market growth due to their developed healthcare systems and large populations[1][3].

Cited Sources:

1. Data Bridge Market Research - Global Baricitinib Market - Industry Trends and Forecast to 2029.
2. PubMed - A Budget Impact and Cost Per Additional Responder Analysis for Baricitinib.
3. Market Research Intellect - Baricitinib Market Size And Projection.
4. AdisInsight - Baricitinib - Eli Lilly and Company/Incyte Corporation.
5. Market Research Intellect - Baricitinib Market Size and Projections.

Last updated: 2024-12-17