OFEV Drug Patent Profile

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

Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-seven patent family members in fifty-three countries.

The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ofev

Ofev was eligible for patent challenges on October 15, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 7, 2029. This may change due to patent challenges or generic licensing.

There have been two 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.

There is one tentative approval for the generic drug (nintedanib esylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OFEV

International Patents:	197
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Patent Applications:	360
Drug Prices:	Drug price information for OFEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OFEV
What excipients (inactive ingredients) are in OFEV?	OFEV excipients list
DailyMed Link:	OFEV at DailyMed

See drug prices for OFEV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OFEV

Constraining patent/regulatory exclusivity:

9,907,756*PED

NDA:

205832

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OFEV

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for OFEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFEV	Capsules	nintedanib esylate	100 mg and 150 mg	205832	4	2018-10-15

US Patents and Regulatory Information for OFEV

OFEV is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,907,756.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	6,762,180*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	6,762,180*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	10,154,990*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	9,907,756*PED				Y

Expired US Patents for OFEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	7,989,474
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	7,119,093
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	7,119,093
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	7,989,474

International Patents for OFEV

When does loss-of-exclusivity occur for OFEV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 OFEV around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20073831
Australia	781939
Portugal	2313087
Brazil	PI0913434	forma de dosagem farmacêutica em cápsula compreendendo uma formulação de um derivado de indolinona em supensão
Japan	2005535684

Supplementary Protection Certificates for OFEV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	1590015-2	Sweden		PRODUCT NAME: NINTEDANIB, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/954 20141121
1830843	00160	Estonia
1830843	2015C/038	Belgium		PRODUCT NAME: NINTEDANIB, OU UN TAUTOMERE DE CELUI-CI, DES MELANGES DE CEUX-CI OU UN SEL DE CELUI-CI, SPECIFIQUEMENTNINTEDANIB SOUS FORME D'ESILATE; AUTHORISATION NUMBER AND DATE: EU/1/14/979/001 20150119
1224170	17/2015	Austria		PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843	C20150026 00160	Estonia		PRODUCT NAME: NINTEDANIIB;REG NO/DATE: EU/1/14/979 19.01.2015

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OFEV

Last updated: November 19, 2025

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Introduction

OFEV (nintedanib) stands at the forefront of the treatment landscape for idiopathic pulmonary fibrosis (IPF) and other fibrosing interstitial lung diseases. Developed by Boehringer Ingelheim, this tyrosine kinase inhibitor has revolutionized disease management by significantly altering disease progression and improving patient outcomes. Given its pivotal role, understanding OFEV’s market dynamics and financial trajectory is crucial for stakeholders involved in pharmaceutical investments, healthcare planning, and competitive analysis.

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Market Overview and Therapeutic Indication Spectrum

OFEV is primarily approved for IPF, a progressive and terminal lung disease characterized by scar tissue buildup in the lungs, leading to declining respiratory function. The global IPF market is projected to reach approximately $2.3 billion by 2025, driven by increasing prevalence, diagnostic advancements, and therapeutic innovation. Beyond IPF, OFEV's indications have expanded to include other fibrosing interstitial lung diseases (ILDs), such as systemic sclerosis-associated ILD, broadening its therapeutic footprint.

Key factors influencing its market size include:

• Rising global prevalence of pulmonary fibrotic conditions.
• Enhanced diagnostic capabilities leading to earlier and more accurate detection.
• Approval of expanding indications, extending potential patient population.

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Market Dynamics

1. Competitive Landscape

The anti-fibrotic market is primarily occupied by OFEV and Roche’s Esbriet (pirfenidib). While both drugs have demonstrated efficacy in slowing IPF progression, nuances in their safety profiles, dosing regimens, and geographic approvals influence market share distribution. OFEV’s once-daily dosing offers advantages over Esbriet, which requires multiple daily doses, impacting patient compliance and preference.

2. Regulatory and Policy Influences

Regulatory agencies like the U.S. FDA and EMA have approved OFEV for IPF since 2014. Recent approvals for additional fibrotic ILDs in regions like Europe and Japan expand its market. Additionally, evolving reimbursement policies and inclusion in national formularies influence accessibility and uptake.

3. Pricing and Reimbursement

OFEV’s pricing, often aligned with high-cost specialty medications, faces scrutiny amid healthcare cost containment efforts. Boehringer Ingelheim strategically negotiates with payers to ensure broad reimbursement, vital for market expansion. Patient assistance programs and value-based agreements also play vital roles in market penetration.

4. Developments in Companion Diagnostics and Biomarkers

Advances in identifying biomarkers predictive of treatment response may facilitate targeted therapy, potentially increasing OFEV’s market share by enabling personalized treatment strategies.

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Financial Trajectory

1. Revenue Growth Trends

OFEV has experienced robust revenue growth since its launch, with net sales surpassing €1.8 billion in 2022 globally. The steady increase reflects increased diagnosis, expanded indications, and geographic expansion. Boehringer Ingelheim’s strategic marketing and minimal generic competition (due to its patent protections and potential patent extensions) sustain revenue growth prospects.

2. Market Penetration and Geographic Expansion

The drug maintains dominant positions in North America, Europe, and parts of Asia-Pacific. Emerging markets, including China and Brazil, exhibit potential for future growth driven by increasing diagnosis rates and healthcare spending.

3. Patent and Exclusivity Landscape

While patent protections bolster revenue, upcoming patent expirations could invite generic competition, threatening near-term revenue prospects. Boehringer Ingelheim’s efforts to secure supplementary patents and develop related formulations aim to mitigate erosion.

4. Pipeline and New Indications

Post-market studies exploring OFEV for other fibrotic and inflammatory conditions suggest potential pipeline extensions. These could diversify revenue streams beyond IPF and related ILDs, bolstering long-term financial stability.

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Risks and Challenges

• Generic and biosimilar competitors post-patent expiration could significantly impact revenue.
• Pricing pressures from healthcare systems threaten profit margins.
• Unmet medical needs persist in terms of treatment options for progressive fibrotic diseases, emphasizing the importance of continued innovation.
• Regulatory hurdles in emerging markets may delay access and commercialization.

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Market Opportunities and Strategic Outlook

1. Expanding Approved Indications

Further approvals for fibrotic and inflammatory diseases present significant revenue opportunities. For example, ongoing clinical trials for OFEV in systemic sclerosis-associated ILD and other fibrosing conditions could cement its position across broader respiratory disorders.

2. Geographic Diversification

Targeted expansion into emerging markets such as China, India, and Southeast Asia can leverage rising healthcare access and infrastructure. Collaborations with local authorities and price negotiations will be pivotal.

3. Value-Based Pricing and Reimbursement Models

Implementing outcome-based pricing strategies aligns drug value with healthcare budgets. Such models improve access while protecting revenue streams.

4. Technological Integration

Utilization of digital health tools—remote monitoring and patient engagement platforms—could enhance adherence, optimize treatment outcomes, and support market growth.

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Key Takeaways

• OFEV holds a dominant position in the IPF treatment market, with revenues reflecting sustained growth driven by expanding indications and geographic reach.
• Competitive landscape dynamics, patent protections, and reimbursement policies significantly influence future financial prospects.
• Diversification through new indications, pipeline developments, and emerging markets offers crucial avenues for sustained revenue growth.
• Addressing pricing pressures and fostering innovative access strategies will be necessary to maximize profitability amid evolving healthcare landscapes.
• Continuous clinical research and personalized medicine approaches stand to reinforce OFEV's market relevance and long-term viability.

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FAQs

1. What factors differentiate OFEV from its primary competitor, Esbriet?
OFEV offers once-daily dosing, which improves patient compliance versus Esbriet’s multiple daily doses. Additionally, differing safety profiles and regional approvals influence prescribing preferences.

2. How might patent expirations impact OFEV’s revenue?
Patent lapses could lead to biosimilar or generic competition, significantly reducing sales and prompting the need for pipeline diversification and patent extensions to safeguard earnings.

3. What are the key growth opportunities for OFEV globally?
Emerging markets and new indications in fibrotic diseases outside IPF, supported by regulatory approvals and local pricing strategies, represent substantial growth avenues.

4. How does reimbursement influence OFEV’s market access?
Reimbursement policies directly affect patient access, especially given OFEV’s high cost. Negotiations and value-based models are critical to expanding treatment coverage.

5. What role do biomarkers play in OFEV’s future landscape?
Biomarkers can enable precise patient stratification, enhancing treatment efficacy and safety, leading to increased adoption and tailored therapeutic approaches.

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References

[1] IQVIA. (2022). Pulmonary Fibrosis Market Analysis.
[2] Boehringer Ingelheim. (2022). OFEV Prescribing Information.
[3] GlobalData. (2022). Fibrosis Drugs Market Outlook.
[4] EMA. (2014). OFEV (nintedanib) approval documents.