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 is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and three 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:	103
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	16
Patent Applications:	2,443
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
Yale University	Phase 2
University of California, San Francisco	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		RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022		RX	Yes	Yes
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-001	May 31, 2018		RX	Yes	No
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-003	May 10, 2022		RX	Yes	Yes
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924-002	Oct 8, 2019		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/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 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

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
Portugal	2288610
Denmark	2288610
Serbia	55263	DERIVATI AZETIDINA I CIKLOBUTANA KAO JAK INHIBITORI (AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS)
Poland	2830662
New Zealand	587928	AZETIDINE AND CYCLOBUTANE DERIVATIVES AS JAK INHIBITORS
Australia	2016244212	ANTIVIRAL JAK INHIBITORS USEFUL IN TREATING OR PREVENTING RETROVIRAL AND OTHER VIRAL INFECTIONS
Spain	2602577

Supplementary Protection Certificates for OLUMIANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2288610	CA 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
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
2288610	CR 2017 00032	Denmark		PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1 /16/1170 20170215
2288610	2017/032	Ireland		PRODUCT NAME: BARACITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/16/1170 20170213
2288610	33/2017	Austria		PRODUCT NAME: BARICITINIB UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/16/1170 (MITTEILUNG) 20170215
2288610	C20170022 00232	Estonia		PRODUCT NAME: BARITSITINIIB;REG NO/DATE: EU/1/16/1170 15.02.2017

Market Dynamics and Financial Trajectory for OLUMIANT

Introduction

OLUMIANT, also known as baricitinib, is a Janus kinase (JAK) inhibitor developed by Eli Lilly and Company. It is primarily used to treat conditions such as rheumatoid arthritis, alopecia areata, and other inflammatory diseases. This article delves into the market dynamics and financial trajectory of OLUMIANT, highlighting its current performance, future projections, and the impact of various market and financial factors.

Current Market Performance

Revenue Growth

In the fourth quarter of 2023, OLUMIANT saw significant revenue growth, with worldwide sales increasing by 18% compared to the same period in 2022, reaching $243.5 million. This growth was driven by increased demand, particularly in the U.S., where revenue jumped by 53% to $66.7 million, despite lower realized prices. Revenue outside the U.S. also increased by 9% to $176.8 million, driven by higher volume[2].

Regional Performance

The drug's performance varies across different regions. In the 7MM (United States, EU4 - Germany, France, Italy, Spain, and the United Kingdom, and Japan), OLUMIANT has established a strong presence, particularly in the treatment of rheumatoid arthritis. The market scenario in these regions is expected to evolve due to extensive research and increased healthcare spending, which will likely expand the market size for OLUMIANT[1].

Future Market Projections

Market Forecast

The market forecast for OLUMIANT is positive, with the drug expected to continue its growth trajectory. The report on OLUMIANT's market forecast from 2023 to 2032 indicates that the drug will remain a significant player in the rheumatoid arthritis market. Emerging therapies and novel approaches to treat rheumatoid arthritis may pose competition, but OLUMIANT's established position and ongoing research and development activities are expected to maintain its market presence[1].

Competitive Landscape

The competitive landscape for OLUMIANT is dynamic, with other emerging products expected to provide tough competition. However, OLUMIANT's strong brand recognition and continuous development activities are likely to help it retain a significant market share. The launch of late-stage emerging therapies in the near future will significantly impact the market, but OLUMIANT's current dominance is expected to be sustained through strategic marketing and R&D efforts[1].

Financial Implications

Royalty Sales and Milestones

Aclaris Therapeutics' decision to sell a portion of its future royalty payments and certain milestones for OLUMIANT to OMERS Life Sciences for up to $31.5 million highlights the financial significance of the drug. This non-dilutive transaction includes a $26.5 million upfront payment and up to $5 million in potential milestone payments based on OLUMIANT sales in 2024. This move strengthens Aclaris' balance sheet and provides financial flexibility without diluting shareholder equity[4].

Impact on Eli Lilly's Financials

Eli Lilly's overall financial performance is significantly influenced by OLUMIANT, among other key products like Mounjaro. In 2023, Eli Lilly reported strong financial results, with total revenues of $34.1 billion, a 20% increase from 2022. The growth in OLUMIANT sales, although not as meteoric as Mounjaro's, contributes to the company's overall revenue and profitability[2][3].

Regulatory and Developmental Activities

Mechanism of Action and Dosage

OLUMIANT's mechanism of action as a JAK inhibitor and its dosage and administration protocols are well-defined. The drug's effectiveness in treating rheumatoid arthritis and other conditions has been supported by extensive clinical trials and regulatory approvals. Ongoing research and development activities, including regulatory milestones, continue to enhance the drug's profile and expand its therapeutic indications[1].

Emerging Therapies and Challenges

The market for rheumatoid arthritis treatments is evolving with the emergence of new therapies. While these emerging products pose a competitive challenge to OLUMIANT, the drug's established position and continuous innovation are expected to help it navigate these challenges. The assessment of these challenges and opportunities is crucial for maintaining OLUMIANT's market dominance[1].

Market Implications and Investor Insights

Market Confidence

The sale of OLUMIANT royalties by Aclaris Therapeutics to OMERS Life Sciences indicates market confidence in the drug's commercial prospects. This transaction suggests that investors and financial institutions believe in the long-term revenue potential of OLUMIANT, particularly for its indication in alopecia areata[4].

Opportunity Cost and Risk Management

While the sale of royalties provides immediate financial benefits, it also involves an opportunity cost. Aclaris Therapeutics is potentially sacrificing long-term revenue streams for immediate liquidity. This decision highlights the balance between short-term financial gains and long-term strategic planning in the pharmaceutical industry[4].

Key Takeaways

• Revenue Growth: OLUMIANT has shown significant revenue growth, driven by increased demand and higher volume.
• Market Forecast: The drug is expected to maintain its market presence despite emerging competition.
• Financial Implications: The sale of royalties and milestones highlights the financial significance of OLUMIANT and provides financial flexibility for companies like Aclaris Therapeutics.
• Regulatory and Developmental Activities: Ongoing research and regulatory milestones continue to support OLUMIANT's market position.
• Market Implications: The drug's commercial prospects are supported by market confidence, but involve strategic risk management.

FAQs

What is OLUMIANT used for?

OLUMIANT (baricitinib) is primarily used to treat rheumatoid arthritis, alopecia areata, and other inflammatory diseases.

How has OLUMIANT performed in terms of revenue in recent years?

In Q4 2023, OLUMIANT's worldwide revenue increased by 18% compared to Q4 2022, reaching $243.5 million.

What are the future market projections for OLUMIANT?

The market forecast indicates that OLUMIANT will continue to be a significant player in the rheumatoid arthritis market from 2023 to 2032, despite emerging competition.

Why did Aclaris Therapeutics sell a portion of its OLUMIANT royalties?

Aclaris Therapeutics sold a portion of its OLUMIANT royalties to OMERS Life Sciences for up to $31.5 million to strengthen its balance sheet and gain financial flexibility without diluting shareholder equity.

How does OLUMIANT contribute to Eli Lilly's financial performance?

OLUMIANT is one of the key products contributing to Eli Lilly's overall revenue and profitability, although its growth is overshadowed by other products like Mounjaro.

What are the potential risks associated with selling OLUMIANT royalties?

The sale of royalties involves an opportunity cost, as Aclaris Therapeutics is potentially sacrificing long-term revenue streams for immediate liquidity.

Sources

1. Research and Markets: "OLUMIANT Drug Insight and Market Forecast - 2032"
2. Eli Lilly Investor Relations: "Lilly Reports Strong Fourth-Quarter 2023 Financial Results and"
3. Drug Discovery Trends: "Eli Lilly's Mounjaro sales projected to triple in 2024"
4. Stock Titan: "Aclaris Therapeutics Announces Sale of OLUMIANT® Royalties and Milestones to OMERS Life Sciences for Up to $31.5 Million"
5. Eli Lilly Investor Relations: "Lilly reports Q3 2024 financial results highlighted by strong volume"

Last updated: 2024-12-16