ofev Drug Patent Profile

Which patents cover Ofev, and what generic alternatives are available?

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
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					Y
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 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	205832-001	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
Slovenia	2878297
Japan	2011522010
Spain	2797546
Cyprus	1112916
Denmark	1830843
Slovenia	2299987
Ukraine	78352	МОНОЭТАНСУЛЬФОНАТ 3-Z-[1-(4-(N-((4-МЕТИЛПИПЕРАЗИН-1-ИЛ)МЕТИЛКАРБОНИЛ)-N-МЕТИЛАМИНО)АНИЛИНО)-1-ФЕНИЛМЕТИЛЕН]-6-МЕТОКСИКАРБОНИЛ-2-ИНДОЛИНОНА, ЕГО МЕТАБОЛИТ И ПРОЛЕКАРСТВА;МОНОЕТАНСУЛЬФОНАТ 3-Z-[1-(4-(N-((4-МЕТИЛПІПЕРАЗИН-1-ІЛ)МЕТИЛКАРБОНІЛ)-N-МЕТИЛАМІНО)АНІЛІНО)-1-ФЕНІЛМЕТИЛЕН]-6-МЕТОКСИКАРБОНІЛ-2-ІНДОЛІНОНУ, ЙОГО МЕТАБОЛІТ ТА ПРОЛІКИ (3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE MONOETHANESULPHONATE, METABOLITE THEREOF, AND PRODRUGS)

Supplementary Protection Certificates for ofev

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1830843	1590034-3	Sweden		PRODUCT NAME: NINTEDANIB, OR A TAUTOMER, THE MIXTURES THEREOF ORA SALT THEROF; IN PARTICULAR NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/979 20150119
1224170	PA2015015	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	300725	Netherlands		PRODUCT NAME: NINTEDANIB, DE TAUTOMEREN DAARVAN EN DE ZOUTEN DAARVAN, IN HET BIJZONDER NINTEDANIB EN FYSIOLOGISCH AANVAARDBARE ZOUTEN DAARVAN, MET NAME NINEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141125
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	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
1224170	SPC/GB15/018	United Kingdom		PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
1830843	PA2015025,C1830843	Lithuania		PRODUCT NAME: NINTEDANIBAS ARBA JO TAUTOMERAS, ARBA JU MISINIAI, ARBA JO DRUSKA; KONKRECIAI NINTEDANIBO ESILATAS; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115

Market Dynamics and Financial Trajectory for OFEV (Nintedanib)

Last updated: December 27, 2025

Executive Summary

OFEV (nintedanib) emerged as a pivotal pharmaceutical in treating idiopathic pulmonary fibrosis (IPF) and certain other fibrotic diseases. Market dynamics for OFEV have evolved rapidly, driven by increasing prevalence of IPF, expanding therapeutic indications, regulatory approvals, and competitive landscape shifts. The global OFEV market demonstrated robust growth projections, with compounded annual growth rates (CAGRs) expected to reach approximately 10-12% over the next five years. Financial trajectories are characterized by rising revenues, driven by patent protections, off-label use explorations, and new dosage formulations, although biosimilar competition and market saturation remain key risks. This analysis dissects the current market landscape, key financial metrics, future drivers, and challenges underpinning OFEV's trajectory.

---

Summary of OFEV's Market Position

Aspect	Details
Active Ingredient	Nintedanib (Tyrosine kinase inhibitor)
Primary Indication	Idiopathic pulmonary fibrosis (IPF)
Regulatory Approvals	FDA (2014), EMA (2015), other regulators (Japan 2015), expanded to other fibroses
Manufacturers	Boehringer Ingelheim (original developer)
Global Market Presence	Approved and marketed across North America, Europe, Japan, and select emerging markets
Major Competitors	Pirfenidone (Roche's Esbriet), newer agents in development

---

Market Dynamics of OFEV

1. Epidemiological Drivers

IPF is a progressive, fatal lung disease with rising incidence, projected to reach 3-6 per 100,000 globally, with an aged demographic largely affected. The global IPF prevalence estimates are increasing due to better diagnostics and aging populations.

• Projected Cases (2023): ~250,000 globally with growth forecast at 5% CAGR over the next decade.
• Impact: Elevated demand for approved antifibrotic therapies like OFEV, especially in industrialized economies.

2. Regulatory Landscape and Expanded Indications

Initially approved for IPF, OFEV's label has expanded:

Year	Indication	Regulatory Agency	Notes
2014	Idiopathic pulmonary fibrosis	FDA, EMA	First approval
2020	Systemic sclerosis-associated interstitial lung disease (SSc-ILD)	FDA, EMA	Expanding use in connective tissue disease-related fibrosis
2022	Other fibrotic conditions (e.g., progressive fibrosing interstitial lung disease)	Regulatory filings	Pending approvals, potential for pipeline growth

3. Competitive and Pipeline Dynamics

• Main Competitors:
  • Pirfenidone (Roche): Market leader in IPF, competitive with OFEV.
  • Nintedanib's differentiation: Broad indications, including non-IPF fibroses.
• Pipeline Innovations:
  • New formulations: Extended-release tablets.
  • Combination therapies and biosimilars (not yet in market).

4. Market Penetration & Adoption

• Physician & Patient Acceptance: Increasing with evidence of efficacy and safety.
• Market Access & Reimbursement: Key to revenue growth, with cost-effectiveness analyses favorable in many regions.

5. Price & Reimbursement Trends

Region	Average Price (per 150 mg dose)	Reimbursement Status	Notes
North America	$9,000 – $12,000/month	Broadly reimbursed	Influenced by formularies
Europe	€6,000 – €8,000/month	Reimbursement varies by country	Access delays, price negotiations
Japan	¥150,000/month	National health system coverage	Price controls apply

---

Financial Trajectory of OFEV

1. Current Revenue and Market Share

Fiscal Year	Revenue (USD Millions)	Market Share (IPF segment)	Growth Rate (YoY)
2020	~$1,200	~25%	+20%
2021	~$1,440	~27%	+20%
2022	~$1,700	~30%	+18%

Note: Data based on Boehringer Ingelheim earnings reports and industry estimates.

2. Revenue Drivers & Forecasts

• Expansion of indications: Contributing to higher patient volumes.
• Market penetration: Growing in Asia-Pacific and Latin America.
• Pricing strategies: Tiered based on region and healthcare systems.
• Emerging threats: Biosimilars and generics could pressure pricing post-patent expiry (expected circa 2034).

3. Patent & Exclusivity Outlook

• Patent Expiry: U.S. patent granted in 2014, expiration likely around 2034, with data exclusivity extending till then.
• Regulatory Data Exclusivity: 8 years in jurisdictions like the EU.

4. Cost & R&D Investment

• Development Costs: Estimated at $1.3 billion over 10 years, per industry benchmarks.
• Manufacturing & Distribution Margins: Approximately 40-50%, contributing to profitability.

5. Financial Risks & Opportunities

Risk Factors	Impact	Mitigation Strategies
Patent expiration	Revenue decline post-2034	Diversification, pipeline development
Competitive biosimilars	Price erosion	Patent strategy, differentiation
Regulatory hurdles in new indications	Delay in revenue streams	Early engagement, robust data
Market saturation	Slowing growth in established markets	Geographical expansion, unmet needs

---

Future Outlook & Drivers

Driver	Impact	Timeline
New indication approvals	Broaden total addressable market (~$3 billion in 2023)	2023-2025
Patient population growth	Increase in diagnosed cases, especially in Asia	2024-2030
Pharmacoeconomic favorability	Reimbursement wins, preferential formulary positioning	2024-2026
Pipeline innovations	Potential new therapeutic formulations, combinations	2025-2030
Biosimilar entrants	Price competition in post-patent era	2034+

---

Comparative Analysis: OFEV vs. Pirfenidone

Feature	OFEV (Nintedanib)	Pirfenidone (Esbriet)
Mechanism	Tyrosine kinase inhibitor	Antifibrotic, multiple pathways
Indications	IPF, SSc-ILD, others	IPF
Pricing	Slightly higher in some markets	Comparable
Side Effect Profile	Diarrhea, liver enzyme elevation	Gastrointestinal, skin rash
Market Penetration	Slightly behind Pirfenidone	Market leader in IPF

---

Regulatory Policies & Market Access

• FDA & EMA: Emphasize real-world evidence for expanded indications.
• Pricing & Reimbursement: Tiered approach; negotiations heavily influence market access.
• Pricing Controls: Growing in Europe and Asia-Pacific, affecting margins.

---

Conclusion

The OFEV market is poised for sustained growth driven by rising disease prevalence, expanding indications, and geographical expansion. Its financial trajectory remains positive, with revenues forecasted to grow at ~10-12% CAGR over the next five years, contingent on successful indication approvals and market penetration.

However, post-2034 patent expiration presents a significant competitive challenge, necessitating investment in pipeline diversification, strategic marketing, and cost management.

---

Key Takeaways

• Market Expansion: OFEV benefits from increasing IPF diagnoses and label expansions into broader fibrotic diseases.
• Revenue Growth: Supported by geographic diversification and increasing adoption; revenues projected to reach ~$2.5 billion globally by 2027.
• Patent & Competition Risks: Patent expiry around 2034 necessitates pipeline innovation.
• Pricing & Access Policies: Variations across regions influence revenue margins; negotiations remain pivotal.
• Pipeline & Innovation: Continued development in alternative formulations, combinations, and biomarker-driven personalized therapy will drive future revenues.

---

FAQs

1. What are the main factors influencing OFEV's market growth?
Epidemiological rise of IPF, expanding indications, regulatory approvals, geographic expansion, and increased physician acceptance.

2. When is OFEV's patent expected to expire, and what does this imply for revenues?
Around 2034 in major markets like the U.S. and EU. Post-expiration, biosimilar competition could exert downward pressure on pricing and market share.

3. How does OFEV compare with its primary competitor, pirfenidone?
OFEV has a broader indication profile and potentially different side effects, but both occupy similar market segments. Pricing differs regionally, impacting adoption.

4. What are the key regulatory challenges facing OFEV?
Regulatory hurdles mainly involve initial approval, indication expansions, and reimbursement policies. Off-label use may pose legal and safety concerns.

5. How can Boehringer Ingelheim sustain OFEV’s financial trajectory amid challenges?
By expanding indications, developing new formulations, entering emerging markets, and investing in pipeline diversification.

---

References

1. Boehringer Ingelheim Annual Reports, 2020-2022.
2. FDA and EMA Regulatory Documents for OFEV, 2014-2022.
3. Global Pulmonary Fibrosis Market Reports, 2022.
4. Industry analyst estimates and publications (Bloomberg, 2023).
5. Patent expiry and biosimilar market outlook, IQVIA Insights, 2022.

Note: All financial figures are estimates based on publicly available data and industry analysis, subject to change.