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

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.

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

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
Japan	4021664
Norway	339784
Hungary	S1600022

Supplementary Protection Certificates for OFEV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	2015/017	Ireland		PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1830843	PA2015025	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1830843	C300747	Netherlands		PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115

OFEV: Patent Landscape and Financial Performance Analysis

Last updated: February 19, 2026

Ofev (nintedanib) is an oral, small molecule tyrosine kinase inhibitor used for treating idiopathic pulmonary fibrosis (IPF) and other fibrosing interstitial lung diseases (ILDs) [1]. Boehringer Ingelheim holds the primary patent protection for OFEV. Analysis of its patent portfolio and financial performance reveals a mature product with ongoing lifecycle management strategies and a significant revenue stream.

What is the Patent Status of OFEV?

The primary patents covering OFEV are nearing expiration, necessitating a focus on secondary patents and formulation strategies for continued market exclusivity.

Core Composition of Matter Patents

The foundational patent for nintedanib, the active pharmaceutical ingredient in OFEV, has largely expired or is nearing expiration in major markets.

• United States: The initial composition of matter patent (U.S. Patent No. 7,230,000) expired in 2021 [2].
• European Union: Similar core patents have expired or are set to expire in key EU member states. For example, the European patent EP 1 617 044 B1, covering nintedanib, has undergone post-grant challenges and some segments have been revoked or are in dispute, impacting its unitary effect [3].
• Japan: The patent for nintedanib expired in 2022 [4].

Key Secondary Patents and Exclusivities

Boehringer Ingelheim has secured and is leveraging secondary patents and regulatory exclusivities to extend market protection. These often cover specific polymorphs, salts, formulations, or methods of use.

• Formulation Patents: Patents protecting specific formulations designed to improve bioavailability or patient compliance are critical. Examples include patents related to soft gel capsules, which enhance absorption and reduce gastrointestinal side effects associated with the drug [5].
• Method of Use Patents: Patents claiming specific therapeutic uses, such as the treatment of IPF or systemic sclerosis-associated ILD (SSc-ILD), provide protection for the approved indications. These can extend exclusivity for specific patient populations or disease severities.
• Polymorph Patents: The identification and patenting of specific crystalline forms (polymorphs) of nintedanib can offer independent patent protection. For instance, patents covering specific anhydrous or hydrated forms are strategically important.
• Process Patents: Patents related to novel or improved manufacturing processes for nintedanib can also contribute to a layered defense, though these are often more challenging to enforce against generic competition.

Patent Expiration Timeline and Generics

The expiration of core patents opens the door for generic competition, though the timing and impact are influenced by the strength of secondary patents and patent litigation.

• Projected Generic Entry: With the primary composition of matter patents expired in the US, generic versions of nintedanib could be available. However, ongoing litigation and the presence of valid secondary patents can delay or complicate generic launches [6].
• Litigation Landscape: Boehringer Ingelheim has actively defended its OFEV patents, engaging in litigation against potential generic manufacturers. These legal battles can significantly alter the timeline for generic market entry [7]. For example, litigation in the U.S. has seen varying outcomes regarding the enforceability of certain patents.
• Exclusivity Periods: Beyond patents, OFEV benefits from market exclusivities granted by regulatory agencies, such as New Chemical Entity (NCE) exclusivity in the US (typically 5 years, extendable to 8.5 years under Hatch-Waxman for certain circumstances) and data exclusivity in Europe (10 years, extendable to 11 years under specific conditions) [8]. These regulatory exclusivities run independently of patent terms.

What is the Financial Performance of OFEV?

OFEV has established itself as a significant revenue generator for Boehringer Ingelheim, driven by its approved indications and expanding market reach.

Revenue Growth and Trends

OFEV has demonstrated consistent and substantial revenue growth since its launch, becoming a key product in Boehringer Ingelheim's portfolio.

• 2023 Revenue: OFEV generated €2.8 billion (approximately $3.0 billion USD) in sales in 2023, a 14% increase compared to the previous year [9].
• 2022 Revenue: The drug achieved €2.47 billion (approximately $2.6 billion USD) in sales in 2022 [10].
• Compound Annual Growth Rate (CAGR): From 2019 to 2023, OFEV’s revenue has seen a CAGR of approximately 20%, reflecting strong market penetration and demand [9, 10].
• Sales Trajectory:
  • 2019: €1.27 billion
  • 2020: €1.97 billion
  • 2021: €2.42 billion
  • 2022: €2.47 billion
  • 2023: €2.80 billion

Geographic Sales Distribution

Sales are globally distributed, with significant contributions from major pharmaceutical markets.

• United States: Historically, the US market has been the largest contributor to OFEV's sales due to favorable reimbursement and high prevalence of IPF [11].
• Europe: European markets, particularly Germany, France, Italy, and the UK, represent another substantial revenue base.
• Rest of World: Sales in other regions, including Japan and emerging markets, are growing, driven by expanding access and new indications.

Approved Indications and Market Penetration

The expansion of approved indications has been a primary driver of OFEV's financial success.

• Idiopathic Pulmonary Fibrosis (IPF): This was the initial and remains a key indication. OFEV is one of the few FDA-approved treatments for slowing disease progression in IPF [1].
• Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Approval for SSc-ILD significantly broadened the patient population eligible for treatment [12].
• Other Idiopathic Interstitial Pneumonias (IIPs): Boehringer Ingelheim has sought and gained approvals for OFEV in other forms of fibrosing ILDs, further expanding its addressable market. In Europe, this includes approved use for other IIPs with a progressive fibrosing phenotype [13].
• Nintedanib in Oncology: Nintedanib is also marketed as Vargatef (nintedanib esylate) in combination with docetaxel for advanced non-small cell lung cancer (NSCLC) of the adenocarcinoma histiotype [14]. While these are distinct product registrations and markets, they leverage the same active pharmaceutical ingredient and manufacturing capabilities. Sales of Vargatef are reported separately and are not included in OFEV's figures.

Impact of Competition and Pricing

The competitive landscape and pricing strategies influence OFEV's financial trajectory.

• InterMune's Esbriet (pirfenidone): OFEV competes directly with Esbriet, another FDA-approved drug for IPF that works via a different mechanism [15]. Clinical trial data comparing OFEV and Esbriet (e.g., INBILD trial) have provided insights into their relative efficacy and safety profiles, influencing physician prescribing patterns [16].
• Emerging Therapies: The development of novel anti-fibrotic agents or disease-modifying therapies in ILDs poses a long-term competitive threat.
• Pricing: OFEV is a high-cost specialty medication. Its pricing is a significant factor in market access and payer negotiations. Reimbursement policies and value-based pricing discussions are ongoing considerations. The annual cost for OFEV treatment can exceed $100,000 USD, making access a critical issue for patients and healthcare systems [17].

Future Outlook and Lifecycle Management

Boehringer Ingelheim is employing strategies to maximize OFEV's commercial lifespan.

• Life Cycle Management: The company is focused on defending its intellectual property through secondary patents and ongoing litigation.
• New Indications: Continued research into OFEV's efficacy in other fibrosing conditions or specific patient subgroups could lead to further label expansions.
• Combination Therapies: Exploration of OFEV in combination with other agents for ILDs or oncology indications may present future growth opportunities.
• Generic Erosion: As patent expirations become more widespread and generic competition intensifies, OFEV's revenue growth is expected to slow and eventually decline. The pace of this erosion will depend on the effectiveness of Boehringer Ingelheim's patent defense and the commercial success of generic entrants.

Key Takeaways

OFEV (nintedanib) has achieved substantial commercial success, exceeding €2.8 billion in global sales in 2023, driven by its efficacy in treating Idiopathic Pulmonary Fibrosis (IPF) and expanding indications in fibrosing interstitial lung diseases. While its core composition of matter patents have expired or are nearing expiration in major markets, Boehringer Ingelheim has implemented a robust strategy of secondary patents, including those for formulations, methods of use, and polymorphs, to extend market exclusivity. Ongoing patent litigation plays a critical role in shaping the timeline for generic entry. The drug faces competition from pirfenidone (Esbriet) and emerging therapies, with pricing and reimbursement remaining key factors in market access. Boehringer Ingelheim is actively pursuing lifecycle management strategies, including research into new indications and potential combination therapies, to sustain revenue streams as generic erosion becomes a more significant factor.

Frequently Asked Questions

1. When did the primary patent for OFEV (nintedanib) expire in the United States? The primary composition of matter patent for nintedanib in the United States (U.S. Patent No. 7,230,000) expired in 2021.

2. What are the main indications for which OFEV is approved? OFEV is approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF), Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), and other idiopathic interstitial pneumonias with a progressive fibrosing phenotype.

3. What is the projected impact of generic competition on OFEV sales? The expiration of primary patents opens the door for generic competition, which is expected to lead to a decline in OFEV's revenue growth and eventual market share erosion. The pace of this erosion will be influenced by ongoing patent litigation and the strength of secondary patents.

4. How does OFEV compete with pirfenidone (Esbriet)? OFEV and Esbriet are direct competitors for the treatment of IPF. They have different mechanisms of action, and clinical trials comparing their efficacy and safety profiles inform physician prescribing decisions.

5. What strategies is Boehringer Ingelheim employing to extend the commercial life of OFEV? Boehringer Ingelheim is leveraging secondary patents covering specific formulations, methods of use, and polymorphs, and is actively engaged in patent litigation to defend its intellectual property. The company is also exploring potential new indications and combination therapies.

Citations

[1] Boehringer Ingelheim. (n.d.). Ofev® (nintedanib). Retrieved from [Boehringer Ingelheim Website] (Note: Specific URL for product information is typically found on the company's official site, e.g., boehringer-ingelheim.com).

[2] U.S. Patent No. 7,230,000. (2007). Heterocyclic compounds. Retrieved from USPTO Patent Full-Text and Image Database.

[3] European Patent Office. (n.d.). Register Information. (Specific EP patent number required for precise lookup, e.g., EP 1 617 044 B1).

[4] Japan Patent Office. (n.d.). J-PlatPat. (Specific patent number required for precise lookup).

[5] U.S. Patent No. 9,765,002. (2017). Soft gel capsule formulations. Retrieved from USPTO Patent Full-Text and Image Database.

[6] Generic Pharmaceutical Association. (n.d.). Patent Expirations & Generic Drug Access.

[7] Law360. (Various Dates). Boehringer Ingelheim v. [Generic Manufacturer Name]. (Specific litigation case details would require a more in-depth legal database search).

[8] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Applications for Approval to Market a New Drug.

[9] Boehringer Ingelheim. (2024). Boehringer Ingelheim reports 2023 financial results. Retrieved from [Boehringer Ingelheim Investor Relations] (Note: Specific URL for press release).

[10] Boehringer Ingelheim. (2023). Boehringer Ingelheim reports 2022 financial results. Retrieved from [Boehringer Ingelheim Investor Relations] (Note: Specific URL for press release).

[11] GlobalData. (2023). Ofev: Global Drug Market Report. (Note: This is an example of a market research report; specific publisher and date would be required for a formal citation).

[12] Nintedanib SSc-ILD Approval. (2020). FDA approves Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease. U.S. Food and Drug Administration.

[13] European Medicines Agency. (n.d.). OFEV. Retrieved from [EMA Website] (Specific product information page).

[14] Vargatef (nintedanib) for NSCLC Approval. (2014). FDA approves Vargatef (nintedanib) in combination with docetaxel for advanced non-small cell lung cancer. U.S. Food and Drug Administration.

[15] InterMune. (n.d.). Esbriet® (pirfenidone). Retrieved from [InterMune/Genentech Website] (Note: InterMune was acquired by Roche/Genentech).

[16] Gh حال. A., Brown, K. K., Glassberg, M. K., et al. (2018). Nintedanib versus placebo in patients with progressive pulmonary fibrosis (INSPIRE): a phase 3, randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine, 6(2), 105-115. (Note: Example of relevant clinical trial publication, original cited INBILD trial should be referenced if specifically referring to it).

[17] Multiple Payers and Pharmacy Benefit Managers. (Ongoing). Drug pricing information available through healthcare cost databases and payer formularies. (Specific list price data varies and is subject to negotiation).