NINTEDANIB ESYLATE - Generic Drug Details

What are the generic drug sources for nintedanib esylate and what is the scope of patent protection?

Nintedanib esylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nintedanib esylate has one hundred and ninety-seven patent family members in fifty-three countries.

There are eight drug master file entries for nintedanib esylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for NINTEDANIB ESYLATE

International Patents:	197
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NINTEDANIB ESYLATE
DailyMed Link:	NINTEDANIB ESYLATE at DailyMed

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

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.

Generic filers with tentative approvals for NINTEDANIB ESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 150MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NINTEDANIB ESYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NINTEDANIB ESYLATE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE

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 NINTEDANIB ESYLATE

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

Expired US Patents for NINTEDANIB ESYLATE

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

International Patents for NINTEDANIB ESYLATE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201001857
Eurasian Patent Organization	200200380
New Zealand	518489	6-position substituted indoline, production and use thereof as a medicament

Supplementary Protection Certificates for NINTEDANIB ESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2015 00036	Denmark		PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150115
1830843	PA2015025	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115

Market Dynamics and Financial Trajectory for Nintedanib Esylate

Last updated: August 18, 2025

Introduction

Nintedanib esylate, marketed as Ofev (or its equivalents in other markets), is a tyrosine kinase inhibitor approved for the treatment of idiopathic pulmonary fibrosis (IPF), certain types of non-small cell lung cancer (NSCLC), and other fibrotic diseases. Since its initial approval by the US Food and Drug Administration (FDA) in 2014, the drug has experienced evolving market dynamics driven by expanding therapeutic indications, increasing prevalence of fibrotic conditions, and advancements in targeted therapies. This analysis explores the current market landscape and projected financial trajectory of nintedanib esylate, considering factors such as geopolitical influence, R&D investments, competitive landscape, and regulatory pathways.

Market Overview and Growth Drivers

Therapeutic Indications Expansion

Nintedanib's primary indications—idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and certain cancers—are characterized by high unmet medical needs. The expanding approval footprint has significantly contributed to its market presence. Specifically:

• IPF: The initial indication. The global IPF market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-9%, driven by increasing diagnosed cases and early diagnosis initiatives (source: GlobalData).

• SSc-ILD: Approved in 2019, this indication has broadened clinical applications and enhanced revenue streams. Growing awareness and clinical acceptance are expected to fuel further uptake.

• Non-small Cell Lung Cancer: Approved for locally advanced, metastatic, or recurrent disease, with promising expansion potential in combination regimens.

Growing Disease Prevalence and Diagnostic Advances

The rising prevalence of fibrotic diseases and lung cancers, coupled with improved diagnostic techniques such as high-resolution CT scans, ensures a consistent pipeline of eligible patients. IPF prevalence was estimated at approximately 13-20 cases per 100,000 globally, with higher rates among older populations (source: Fletcher et al., 2020). This demographic trend aligns with increased sales prospects.

Regulatory and Patent Dynamics

While patent protection for original formulations is set to expire in various jurisdictions between 2024-2026, strategic patent extensions, orphan designation, and regulatory exclusivity buffers maintain market competition barriers. The introduction of biosimilars or generics is anticipated but remains limited due to complex manufacturing and patent landscapes.

Market Entry Barriers and Competitive Landscape

Nintedanib faces competition primarily from pirfenidone (Esbriet), another IPF-approved drug with comparable efficacy and safety profiles. The decision-making of clinicians hinges on tolerability, risk-benefit ratios, and insurance coverage. The coexistence of these therapies sustains market competition but also condenses margins due to pricing pressures.

Emerging therapies, including nintedanib combinations with immunotherapies or anti-fibrotic agents, could reshape the landscape, contingent on positive trial outcomes and regulatory approval.

Financial Trajectory and Forecasts

Sales Trends and Revenue Projections

In 2022, global sales of nintedanib approximated $1.5 billion, with approximately 60% originating from IPF treatment (source: IQVIA). Analysts project a CAGR of 8-10% through 2028, driven by:

• Expanded indications: Anticipated approval for additional fibrotic disorders like progressive fibrosing interstitial lung diseases.
• Geographical expansion: Entry into emerging markets such as China and parts of Southeast Asia, expanding patient access.
• Pricing and reimbursement strategies: Success depends on negotiations with payers and the inclusion in national formularies, which influence market penetration.

Research and Development Investment Impact

Pharmaceutical companies continue investing heavily in R&D to optimize nintedanib’s efficacy, explore novel indications, and develop combination therapy regimens. These investments, while costly, aim to extend patent protections or gain approval for orphan indications, ultimately boosting revenues.

Potential Market Challenges

• Patent Expiry and Generic Competition: The expiration of key patents could trigger significant generic entry, risking revenue erosion. However, complex patent landscapes and regulatory data exclusivities act as short-term barriers.

• Pricing Pressures and Market Access: Governments and payers are increasingly scrutinizing high-cost therapies. Price negotiations and healthcare policies could stifle revenue growth.

• Emerging Competitors: New anti-fibrotic agents and molecular targets under investigation could threaten nintedanib’s market share, especially if they demonstrate superior efficacy or safety profiles.

Forecasted Financial Outcomes

Predicted sales of nintedanib are expected to reach approximately $2.2 billion by 2028, assuming successful expansion of indications and geographies, stable patent protections, and favorable market access conditions. The growth rate may slow near patent cliffs but can be sustained through new indications and combination therapies.

Market Dynamics Influences

Geopolitical and Regulatory Environment

Regulatory frameworks, particularly in China and India, are evolving to accelerate approval processes for innovative drugs, offering growth opportunities. Conversely, trade tensions and drug price control policies pose risks. Recent regulatory guidance in the US and EU emphasizes early approval pathways and accelerated reviews for rare diseases, potentially shortening time-to-market.

Manufacturing and Supply Chain Considerations

Global supply chain disruptions, especially post-pandemic, challenge consistent drug supply. Companies investing in localized manufacturing hubs mitigate risks and ensure market continuity.

Emerging Therapeutic Strategies

Gene therapies, anti-fibrotic combinatory regimens, and biomarkers for patient stratification are in experimental stages. Successful integration could redefine market boundaries and accelerate revenue growth.

Key Takeaways

• Nintedanib esylate, primarily marketed as Ofev, maintains a strong position within the antifibrotic therapy landscape, fueled by expanding indications and global disease prevalence.
• Market growth is underpinned by increasing IPF and SSc-ILD prevalence, diagnostic advancements, and regulatory approvals for new indications, with forecasts indicating a CAGR of approximately 8-10% through 2028.
• Patent expiries and evolving regulatory environments pose significant risks; however, strategic patent protections and new clinical data can sustain revenue streams.
• Competition from pirfenidone and emerging therapies influences market share, emphasizing the need for differentiated positioning and combination therapy development.
• Geopolitical shifts, healthcare policy reforms, and supply chain stability are critical external factors that will shape the financial trajectory.
• Investment in R&D targeting novel indications, personalized medicine, and combination regimens will be vital for long-term market viability.

Conclusion

Nintedanib esylate’s market dynamics reflect a complex interplay of clinical, regulatory, and commercial factors. Its trajectory hinges on successful expansion into new therapeutic areas, effective patent and market access strategies, and responsiveness to emerging competitor threats. Organizations positioned to navigate these landscapes effectively can capitalize on this promising yet challenging market environment.

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FAQs

1. What are the main indications for nintedanib esylate currently?
Nintedanib is primarily indicated for idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and certain types of non-small cell lung cancer (NSCLC).

2. How does patent expiry impact nintedanib’s market share?
Patent expiries expose the drug to generic competition, risking revenue decline. However, patent protections, regulatory exclusivity, and development of new indications can mitigate this effect temporarily.

3. What are the key competitors to nintedanib in the antifibrotic market?
Pirfenidone (Esbriet) is the principal competitor. Emerging therapies and combination protocols pose additional competitive threats.

4. How might regulatory changes influence the future of nintedanib?
Regulatory reforms that facilitate accelerated approvals, especially for rare diseases, can enhance market access and sales. Conversely, increased pricing regulations could reduce profitability.

5. Which emerging markets hold the most growth potential for nintedanib?
China, India, and Southeast Asian countries due to rising disease prevalence, expanding healthcare infrastructure, and evolving regulatory landscapes present significant growth opportunities.

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References

[1] GlobalData. “IPF Market Report 2022.”
[2] Fletcher, M., et al. “Prevalence and diagnostic challenges in idiopathic pulmonary fibrosis.” Lancet Respir Med, 2020.
[3] IQVIA. “Pharmaceutical Market Insights 2022.”