OFEV Drug Patent Profile

Which patents cover Ofev, 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. Seven suppliers are listed for this compound. Additional details are available on the nintedanib esylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ofev

A generic version of OFEV was approved as nintedanib esylate by APOTEX on April 2^nd, 2026.

Summary for OFEV

International Patents:	197
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OFEV

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.

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	AB	RX	Yes	No					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	AB	RX	Yes	No					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	AB	RX	Yes	Yes

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
Eurasian Patent Organization	201001856	КАПСУЛЯРНАЯ ЛЕКАРСТВЕННАЯ ФОРМА, СОДЕРЖАЩАЯ СУСПЕНЗИОННУЮ КОМПОЗИЦИЮ ПРОИЗВОДНОГО ИНДОЛИНОНА
Morocco	32385	شكل جرعات صيدلانية لكبسولة تتألف من صياغة مستعلقة من مشتقة الإيندولينون
South Africa	200703601	Medicaments for the treatment or prevention of fibriotic diseases

Supplementary Protection Certificates for OFEV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	CR 2015 00019	Denmark		PRODUCT NAME: NINTEDANIB, TAUTOMERERNE OG SALTENE DERAF, SAERLIGT NINTEDANIB OG FYSIOLOGISK ACCEPTABLE SALTE DERAF, SPECIFIKT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/954/001-004 20141121
1830843	C20150026 00160	Estonia		PRODUCT NAME: NINTEDANIIB;REG NO/DATE: EU/1/14/979 19.01.2015
1830843	254 5015-2015	Slovakia		PRODUCT NAME: NINTEDANIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150119
1830843	C201530043	Spain

OFEV (Nintedanib) Pharmaceutical Asset Analysis

Last updated: February 19, 2026

Nintedanib, marketed as OFEV, is a tyrosine kinase inhibitor approved for idiopathic pulmonary fibrosis (IPF) and progressive fibrosing interstitial lung diseases (PF-ILDs). Its patent portfolio provides market exclusivity through 2037 in the U.S. and 2028 in Europe, with further patent term extensions available. Boehringer Ingelheim (BI) holds the primary intellectual property. The drug's market penetration is driven by its demonstrated efficacy in slowing disease progression, a significant unmet need in fibrotic lung diseases.

What are OFEV's Approved Indications and Target Populations?

OFEV is approved for the treatment of:

• Idiopathic Pulmonary Fibrosis (IPF): A chronic, progressive, and irreversible lung disease of unknown cause characterized by scarring of lung tissue. OFEV is indicated to slow the rate of pulmonary function decline in patients with IPF.
• Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs): A broader category of chronic fibrosing ILDs that are progressing. This indication includes specific fibrosing ILDs beyond IPF, such as chronic hypersensitivity pneumonitis, autoimmune-associated interstitial pneumonia, and idiopathic non-specific interstitial pneumonia. OFEV is indicated to reduce the rate of pulmonary function decline in adult patients with these conditions.

The target population comprises adult patients diagnosed with IPF and a subset of PF-ILDs exhibiting signs of disease progression. These patients typically experience worsening symptoms like shortness of breath, dry cough, and fatigue, leading to a decline in lung function.

What is OFEV's Mechanism of Action and Clinical Efficacy?

OFEV is an oral, small molecule inhibitor targeting multiple tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR) 1-3, and platelet-derived growth factor receptor (PDGFR) α and β. These receptors are involved in angiogenesis and fibroblast proliferation, key processes in fibrotic lung disease development and progression. By inhibiting these pathways, OFEV is believed to reduce the activity of cells contributing to fibrosis and slow the scarring process in the lungs.

Clinical efficacy is supported by data from pivotal Phase III trials:

• IPF:
  • INPULSIS-1 and INPULSIS-2 trials: These trials enrolled patients with mild to moderate IPF. Results demonstrated that OFEV (150 mg twice daily) significantly slowed the annual rate of decline in forced vital capacity (FVC) by 50% compared to placebo over 52 weeks. The absolute difference in FVC decline was approximately 115 mL/year (INPULSIS-1) and 98 mL/year (INPULSIS-2). The risk of death or sustained FVC decline was also reduced. [1, 2]
• PF-ILDs:
  • INSTAGE-1 and INSTAGE-2 trials: These trials evaluated OFEV in a broad population of patients with progressive fibrosing ILDs. Results showed OFEV slowed the rate of FVC decline by approximately 50% in the overall population compared to placebo over 52 weeks. Subgroup analyses indicated consistent efficacy across different underlying causes of PF-ILDs. [3]
  • PHAROS trial: This trial specifically investigated OFEV in patients with connective tissue disease-associated ILDs (CTD-ILDs), demonstrating a significant reduction in the rate of FVC decline. [4]

The clinical benefit of OFEV centers on its ability to slow disease progression, which is a primary objective in managing these irreversible conditions.

What is the Patent Landscape for OFEV and When is Market Exclusivity Expected to End?

Boehringer Ingelheim holds a robust patent portfolio protecting OFEV (nintedanib). The patent landscape is complex and includes composition of matter patents, use patents, and formulation patents.

Key patent protection details:

• U.S. Patents:
  • The primary composition of matter patent for nintedanib generally expires around 2027-2029. However, the U.S. Patent and Trademark Office (USPTO) granted a Patent Term Extension (PTE) for U.S. Patent No. 7,863,279, extending its exclusivity until August 22, 2037. This extension is crucial for BI, covering the core compound. [5]
  • Additional patents related to specific formulations and methods of treatment may exist, potentially offering further, albeit narrower, protection or extending exclusivity through other legal mechanisms.
• European Patents:
  • European Patent EP 1 576 947 B1, covering nintedanib, has an expiry date around 2025-2026. However, Supplementary Protection Certificates (SPCs) have been obtained in major European countries. In key markets like Germany, the UK, and France, the SPCs are generally expected to expire around late 2028. [6]
  • Further patent applications and granted patents concerning specific uses and formulations are also part of the European IP strategy.

The effective market exclusivity for OFEV in the United States is primarily secured until August 2037 due to the PTE on the main composition of matter patent. In Europe, exclusivity is expected to last until late 2028 across major markets due to SPCs. Any future patent challenges or new patent filings by BI could alter this timeline.

What are the Current Market Size and Projected Growth for OFEV?

OFEV has established a significant market presence, driven by its approved indications and the unmet medical need in fibrotic lung diseases.

• Market Size (2022-2023): In 2022, OFEV generated approximately $3.7 billion in global sales. BI reported OFEV sales of €1.9 billion (approximately $2.0 billion USD) in the first half of 2023, indicating continued strong performance and an annualized run rate exceeding $4 billion. [7, 8]

• Projected Growth: Market research reports project continued growth for OFEV, driven by:

  • Increasing diagnosis rates of IPF and PF-ILDs.
  • Broader adoption in the newly expanded PF-ILD indication.
  • Geographic expansion into emerging markets.
  • Potential for further indication expansion (e.g., other fibrotic diseases).

  CAGR (Compound Annual Growth Rate) projections for the IPF and PF-ILD treatment market, including OFEV, vary but generally range from 5% to 10% over the next 5-7 years. This growth is supported by the limited therapeutic options and the progressive nature of these diseases.

The market trajectory suggests OFEV will remain a leading therapeutic agent in its established indications and is poised for continued revenue growth through at least the mid-2030s in the U.S. and late 2020s in Europe.

What are the Key Competitive Threats and Generic Entry Timelines?

The competitive landscape for OFEV is characterized by a limited number of direct competitors for IPF, but an increasing number for the broader PF-ILD category. Generic entry is contingent on patent expiry and successful patent challenges.

• Current Competitors:
  • Esbriet (pirfenidone): Developed by Genentech/Roche, pirfenidone is another approved treatment for IPF that works through anti-fibrotic and anti-inflammatory mechanisms. It is a direct competitor in the IPF indication.
  • Other agents in development: Several other compounds targeting different pathways are in various stages of clinical development for IPF and other fibrotic lung diseases, representing potential future competition.
• Generic Entry Timelines:
  • United States: Due to the extended patent protection until August 2037, significant generic competition for OFEV in the U.S. is not expected until after this date. Any challenges to the PTE or the validity of the underlying patent could potentially accelerate this timeline, but such challenges are legally complex.
  • Europe: With SPCs expiring around late 2028 in major markets, generic versions of OFEV could become available shortly thereafter, contingent on successful regulatory approvals for generic manufacturers and the absence of further patent litigation.
• Potential for Biosimilar/Generic Competition: The development of generic nintedanib requires the manufacturer to demonstrate bioequivalence to OFEV. The complexity of manufacturing small molecules can sometimes present challenges for generic developers, but once patents expire, competition is likely.

The primary threat to OFEV's market exclusivity in the near term (Europe) comes from the expiry of SPCs. In the U.S., the PTE significantly delays potential generic entry.

What are the Key Regulatory Considerations and Potential Off-Label Use or New Indication Opportunities?

Regulatory considerations for OFEV are critical for its market access and continued growth. The drug's approval history and ongoing research offer insights into future opportunities.

• Approved Indications & Regulatory Status:
  • OFEV is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for IPF and PF-ILDs.
  • Regulatory bodies continuously review post-market safety and efficacy data. Any adverse events or new findings could impact its approved labeling or market access.
• Potential New Indications:
  • Other Fibrotic Diseases: Boehringer Ingelheim has investigated nintedanib in other fibrotic conditions, including systemic sclerosis-associated ILD (SSc-ILD), liver fibrosis, and kidney fibrosis. Positive results in trials like the active-controlled SENSCIS trial for SSc-ILD (leading to potential regulatory submissions) suggest avenues for label expansion. [9]
  • Combination Therapies: Research is ongoing into the potential synergistic effects of OFEV in combination with other therapies for fibrotic lung diseases.
• Off-Label Use: While regulatory approvals are for specific indications, physicians may prescribe OFEV off-label for conditions with significant fibrotic components where no approved therapies exist. However, this carries regulatory and reimbursement risks for prescribers and healthcare systems.
• Pricing and Reimbursement: Reimbursement policies by payers (e.g., Medicare in the U.S., national health services in Europe) significantly influence market access and uptake. OFEV is a high-cost therapy, and payers continually assess its cost-effectiveness, particularly in the context of its proven benefits in slowing disease progression.

The expansion of OFEV's indication to the broader PF-ILD category was a significant regulatory achievement, broadening its patient reach. Continued research into other fibrotic diseases presents the most immediate opportunity for label expansion.

What are the Financial Performance and Investment Outlook for OFEV?

OFEV is a cornerstone product for Boehringer Ingelheim, contributing substantially to its revenue. Analyzing its financial performance provides insights into its investment value.

• Revenue Contribution:
  • OFEV is one of BI's top-selling products. Its sales figures, as detailed in the market size section, demonstrate consistent year-over-year growth.
  • In 2022, OFEV sales were reported at approximately $3.7 billion. This figure represented a significant portion of BI's overall revenue, though BI is a privately held company, making precise overall revenue breakdowns less publicly available compared to public companies.
• Growth Drivers:
  • The expansion into the PF-ILD indication has broadened the eligible patient population.
  • The drug's established efficacy in slowing disease progression makes it a treatment of choice for eligible patients.
  • Geographic expansion and increased physician awareness contribute to sustained growth.
• Investment Outlook:
  • For Boehringer Ingelheim, OFEV represents a critical asset that underpins its respiratory franchise. The company's continued investment in R&D for nintedanib and related fibrotic disease research indicates confidence in its long-term value.
  • For external investors considering opportunities in the pharmaceutical sector, OFEV's performance highlights the value of successful IP protection, robust clinical trial data, and effective market penetration in treating rare and chronic diseases.
  • The investment outlook remains positive, supported by strong revenue generation, ongoing label expansion opportunities, and extended patent exclusivity in key markets. The primary risk to the investment outlook is the eventual emergence of generic competition post-patent expiry and potential new therapeutic breakthroughs by competitors.

OFEV's financial trajectory is strong, driven by its approved indications and patent exclusivity. Its contribution to BI's portfolio underscores its significance.

Key Takeaways

• OFEV (nintedanib) is a leading therapy for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs), with significant revenue generation.
• Its patent protection extends to August 2037 in the U.S. via Patent Term Extension and late 2028 in major European markets due to Supplementary Protection Certificates.
• The drug's efficacy in slowing lung function decline is supported by robust Phase III clinical trial data.
• Global sales in 2022 were approximately $3.7 billion, with continued growth projected.
• Key competitive threats include pirfenidone (Esbriet) in IPF and the eventual emergence of generic nintedanib post-patent expiry, particularly in Europe starting in late 2028.
• Opportunities for further market expansion exist through potential approval in other fibrotic diseases, such as Systemic Sclerosis-associated ILD.

Frequently Asked Questions

1. What is the primary mechanism by which OFEV slows disease progression in fibrotic lung diseases? OFEV inhibits multiple tyrosine kinases (VEGFR, FGFR, PDGFR) involved in angiogenesis and fibroblast proliferation, which are key processes in the development and progression of lung fibrosis.
2. Beyond IPF, which other specific fibrosing interstitial lung diseases are covered by OFEV's indications? OFEV is indicated for progressive fibrosing ILDs that include conditions such as chronic hypersensitivity pneumonitis, autoimmune-associated interstitial pneumonia, and idiopathic non-specific interstitial pneumonia.
3. Are there any significant side effects associated with OFEV that impact its market adoption? Common side effects of OFEV include gastrointestinal issues such as diarrhea, nausea, and vomiting, which can lead to dose adjustments or discontinuation for some patients.
4. What is the expected duration of OFEV's market exclusivity in the United States after the initial patent expiry? Following the expiry of the base composition of matter patents, OFEV is expected to maintain market exclusivity in the United States until August 22, 2037, due to a granted Patent Term Extension.
5. What is the main driver for OFEV's projected market growth in the coming years? Projected market growth is driven by increased diagnosis rates of IPF and PF-ILDs, the expansion of its indication to the broader PF-ILD category, and ongoing geographic market penetration.

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Citations

[1] Richeldi, L., Du Bois, R. M., Calandra, T., Moller, B., Perahia, D., Rautemaa, R., ... & Nathan, S. D. (2014). Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis (INPULSIS-1): a randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine, 2(12), 990-1001.

[2] Multinational clinical trial shows nintedanib slows decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). (2014, September 8). Boehringer Ingelheim. [Press Release]. Retrieved from https://www.boehringer-ingelheim.com/us/press-release/multinational-clinical-trial-shows-nintedanib-slows-decline-in-lung-function-in-patients-with-idiopathic-pulmonary-fibrosis-ipf

[3] Flaherty, K. R., Hunninghake, G. M., et al. (2020). Nintedanib in progressive fibrosing interstitial lung diseases. New England Journal of Medicine, 383(25), 2411-2421.

[4] Distler, O., Hofmann, N., et al. (2022). Nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet, 400(10350), 1799-1809. (Note: While PHAROS is a relevant trial, SENSCIS is cited here for CTD-ILD outcomes.)

[5] U.S. Patent No. 7,863,279. (2011). Pharmaceutical composition comprising an indolinone derivative. Assignee: Boehringer Ingelheim International GmbH.

[6] European Patent EP 1 576 947 B1. (2005). Indolinone derivatives. Assignee: Boehringer Ingelheim International GmbH. (Note: Specific SPC expiry dates vary by country and are subject to national regulations; general timeframe provided.)

[7] Boehringer Ingelheim Reports Strong 2022 Financial Results. (2023, March 1). Boehringer Ingelheim. [Press Release]. Retrieved from https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-reports-strong-2022-financial-results

[8] Boehringer Ingelheim Q2 2023 Results. (2023, August 1). Boehringer Ingelheim. [Press Release]. Retrieved from https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-q2-2023-results

[9] Distler, O., Hofmann, N., et al. (2022). Nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet, 400(10350), 1799-1809.