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. Eight 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Patent Applications:	4,636
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

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.

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	6,762,180*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	AB	RX	Yes	Yes	6,762,180*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	AB	RX	Yes	No	10,154,990*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	7,119,093
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	7,989,474

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
Argentina	072060
Australia	2009254556
Brazil	PI0913235

Supplementary Protection Certificates for ofev

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	92681	Luxembourg		PRODUCT NAME: INDOLINONES SUBSTITUEES EN POSITION 6, LEUR PREPARATION ET LEUR UTILISATION EN TANT QUE MEDICAMENTS; FIRST REGISTRATION: 20141121
1224170	C300725	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 20141121
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

OFEV Market Dynamics and Financial Trajectory: Sales Trends, Contract Drivers, and Exclusivity-to-Generic Timeline

Last updated: July 21, 2026

OFEV (nintedanib) is a long-cycle, specialty-priced antifibrotic with revenue driven by interstitial lung disease (ILD) uptake, payer access, persistence, and label expansion across idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing ILDs. Financial trajectory is shaped by (1) cohort growth in IPF and progressive pulmonary fibrosis (PPF), (2) discontinuation and dose intensity in real-world settings, (3) payer tightening through prior authorization and step edits, and (4) competitive pressure from antifibrotic peers and near-term biosimilar/generic substitution risk being structurally limited by patent and formulation controls for nintedanib.

What has driven OFEV sales growth and market share performance in IPF and PPF?

OFEV’s market dynamics track the expansion of its clinically distinct niche: reducing disease progression in IPF and, after subsequent approvals, in other progressive fibrosing ILDs. Commercial outcomes depend less on rapid line extensions and more on controlled penetration into pulmonology and ILD centers, then converting that pipeline into durable, reimbursed treatment.

Which indications are the main revenue drivers for OFEV?

• Idiopathic pulmonary fibrosis (IPF): Core revenue base; high prescriber familiarity and long-standing reimbursement precedent.
• Progressive fibrosing interstitial lung diseases (PPF): Expansion driver; increases total addressable patient pool beyond IPF.

What payer and access mechanisms shape OFEV uptake?

• Prior authorization and medical-necessity criteria: Commonly require confirmation of diagnosis and evidence of progression.
• Step edits and formulary tiering: Specialty pharmacy rules can affect conversion from initial patient identification to first fill.
• Dose and adverse-event management: Gastrointestinal events and liver enzyme elevations are key discontinuation levers, influencing net sales through persistence and dose reductions.

How does persistence and adherence affect OFEV revenue?

OFEV is taken continuously, so churn is revenue-relevant. In practice, persistence is most sensitive to:

• GI tolerability (diarrhea, nausea), managed via dose reductions and supportive care.
• Liver monitoring compliance and dose interruption patterns.
• Treatment discontinuation after clinical decline.

Competitive positioning: how does OFEV compare with antifibrotics?

The competitive set is primarily:

• Pirfenidone (Esbriet) for IPF
• Other ILD management standards (often adjunctive rather than directly substitutive)

OFEV’s market share is influenced by:

• Patient-level tolerability differences across drug classes
• Prescriber preference patterns at ILD centers
• Payer preference arrangements tied to outcomes data and budget impact

How has OFEV’s financial trajectory evolved across recent fiscal periods?

OFEV financial performance is best understood through the lens of Boehringer Ingelheim’s consolidated specialty growth pattern for its respiratory franchise and the long-lived nature of antifibrotic treatment. Its trajectory typically follows:

1. Patient growth in IPF and progressive fibrosing ILDs
2. Contract and reimbursement dynamics
3. Expected volatility from adverse event profiles and real-world discontinuation

What does the revenue model look like for a continuous oral antifibrotic?

For continuous oral therapy, revenue is a function of:

• Treated patient volume (new starts and switching)
• Treatment duration (persistence)
• Net price after rebates, chargebacks, and discounts
• Seasonal and reporting cadence (start-up ramps from pipeline conversion)

Key financial inflection points to monitor for OFEV

• Label or guideline reinforcement for PPF: can increase prescriber confidence and payer acceptance.
• Real-world persistence signals from claims databases: affect future net sales expectations.
• Payer contracting: formulary wins can create step-function increases in dispensed volume.
• Generic/biosimilar risk: in this class, true substitution hinges on full patent and regulatory exclusivity clearance rather than therapeutic substitution.

When does OFEV lose exclusivity, and what generic entry risks exist?

Commercial substitution risk is determined by the regulatory exclusivity stack and the strength of the patent estate covering nintedanib drug substance, formulations, dosing regimens, and manufacturing. For small molecules like nintedanib, generic entry risk is typically tied to:

• Orange Book patent expiration
• Any method-of-use or formulation barriers
• Potential Paragraph IV certifications for ANDA holders

What patents protect nintedanib (OFEV) and related formulations?

The OFEV patent estate usually includes layers that can delay ANDA approvals and/or limit generic launch design around:

• drug substance and intermediates
• solid-state forms and formulations
• methods of treatment for fibrosis indications
• manufacturing processes

What is the Orange Book status of OFEV?

Orange Book status determines the practical timeline for generic approval timing windows under the Hatch-Waxman framework. It also dictates the likelihood of Paragraph IV litigation:

• If listed patents remain unexpired or are difficult to carve around, ANDA sponsors may defer approvals or litigate.

When does exclusivity end versus when can generic launch?

For generics, two dates matter:

• Patent expiration: when the right to exclude a generic from the market ends.
• ANDA approval timing and any stays: if litigation triggers 30-month stays or settlement carve-outs.

What patent litigation affects OFEV, including Paragraph IV challenges?

Paragraph IV filings drive market-impact events: generic approvals that are launched on schedule if patent barriers are cleared, or delayed if courts stay or enter injunctions.

How do OFEV Paragraph IV challenges typically impact market dynamics?

• Immediate price pressure once a generic is launched or authorized for early distribution.
• Settlement-driven “authorized generic” timing: can mute price erosion compared with full third-party entry.
• Court rulings that sustain injunctive relief can delay generic competition.

What to track in OFEV litigation dockets and settlement terms

• whether the litigation targets drug substance, formulation, or methods
• whether the settlement provides a “no-launch” period or a delayed launch date
• carve-out designs (dose strength, formulation type, or patient subset)

What formulations are protected by OFEV patents and how does that impact design-around?

OFEV is an oral capsule product, with formulation and solid-state aspects often central to IP strategy for small-molecule drugs. These layers matter for:

• ANDA formulation selection
• bioequivalence design
• potential infringement theories around solid-state form or release characteristics

Which formulation features can create IP barriers for ANDA sponsors?

• excipient selection and capsule composition
• solid-state form and crystallinity constraints
• manufacturing process controls that affect impurity profiles
• specific dosing regimens tied to methods of use

How does OFEV’s FDA regulatory status affect competitive timing and access?

OFEV’s regulatory status affects:

• the feasibility of generic approval pathways (ANDA)
• timing of label expansion changes
• switching opportunities based on therapeutic equivalence and interchangeability

What FDA approvals matter for OFEV revenue?

• initial approval for IPF
• subsequent expansions for other progressive fibrosing ILDs
• any labeling changes that alter payer coverage criteria

Which regulatory pathway governs generic entry risk?

• ANDA under Hatch-Waxman for nintedanib as a small molecule
• Pediatric exclusivity and other statutory protections, if applicable, can extend post-NDA timing

How strong is the patent estate for OFEV versus antifibrotic peers?

In antifibrotics, the difference between a stable long-term franchise and a near-term erosion case is mostly:

• how many independent patent families remain valid into the later years
• how hard it is to design around formulation or method-of-use coverage
• whether litigation settlements narrow the patent runway

What would “strong” look like from a business risk lens?

• multiple expiry dates across independent claims
• meaningful barriers beyond just the initial composition-of-matter family
• litigation history that results in delayed generic launch

What is the commercial outlook for OFEV amid payer tightening and competitive substitution?

OFEV’s commercial resilience relies on maintaining:

• formulary access (relevant to net price and volume)
• tolerability management protocols that sustain persistence
• prescriber confidence for PPF indications where diagnosis and progression criteria determine who qualifies

Key market variables that can shift financial trajectory

• Net price: payer contract outcomes and rebating dynamics
• Patient mix: ILD severity and progression timing affect dosing continuity
• Discontinuation risk: GI and hepatic adverse events alter treatment duration
• Competitive share movement: changes in prescribing across antifibrotics

Key Takeaways

• OFEV’s revenue engine is continuous use in IPF and progressive fibrosing ILDs, with persistence and payer access driving the financial slope.
• Exclusivity and the OFEV patent estate determine real generic entry timing under Hatch-Waxman; generic risk is not purely competitive substitution risk.
• Litigation outcomes for ANDA Paragraph IV challenges are the decisive near-to-mid-term market-impact events.
• Commercial upside and downside are both heavily payer- and tolerability-driven rather than driven by short-lived prescribing cycles.

FAQs

1. How do prior authorization requirements for progressive fibrosing ILDs affect OFEV first-fill and persistence?
2. What indicators in claims data best predict OFEV discontinuation risk due to gastrointestinal adverse events?
3. Which patent categories (drug substance vs formulation vs method-of-use) most commonly block OFEV ANDA approvals?
4. How do settlement agreements in OFEV Paragraph IV cases typically influence the timing of generic launches?
5. How does OFEV net price erosion compare with pirfenidone under typical managed care contracting?

References

No citations were provided in the prompt.

DrugChatter Q&A for OFEV

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