DEFITELIO Drug Patent Profile

When do Defitelio patents expire, and what generic alternatives are available?

Defitelio is a drug marketed by Jazz Pharms Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in sixteen countries.

The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Defitelio

Defitelio was eligible for patent challenges on March 30, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 22, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DEFITELIO

International Patents:	25
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for DEFITELIO
What excipients (inactive ingredients) are in DEFITELIO?	DEFITELIO excipients list
DailyMed Link:	DEFITELIO at DailyMed

See drug prices for DEFITELIO

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

Constraining patent/regulatory exclusivity:

11,236,328

NDA:

208114

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Recent Clinical Trials for DEFITELIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New York Medical College	Phase 2
Gregory Yanik	Phase 1
Jazz Pharmaceuticals	Phase 1

See all DEFITELIO clinical trials

Paragraph IV (Patent) Challenges for DEFITELIO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEFITELIO	Injection	defibrotide sodium	200 mg/2.5 mL	208114	1	2024-12-27

US Patents and Regulatory Information for DEFITELIO

DEFITELIO is protected by five US patents.

This potential generic entry date is based on patent 11,236,328.

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
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,236,328
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,746,348		Y
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,085,043		Y

International Patents for DEFITELIO

When does loss-of-exclusivity occur for DEFITELIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

India

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

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 DEFITELIO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2012383169
Brazil	112014031934
Canada	2874960

Last updated: July 27, 2026

DEFITELIO (defibrotide) market dynamics and financial trajectory: uptake, pricing, payer behavior, and exclusivity/patent overhang

DEFITELIO (defibrotide) generates revenue in a narrow, high-acuity transplant niche and trades on clinical standard-of-care positioning for pediatric and adult severe hepatic veno-occlusive disease (VOD), including after hematopoietic stem cell transplant. Post-launch growth has been constrained by (1) event incidence being limited to high-risk VOD populations, (2) inpatient-only administration requirements, and (3) competitive and policy dynamics tied to transplant center formularies. Longer-run financial trajectory hinges on remaining regulatory exclusivity, patent estate strength around formulation and methods of use, and the probability and timing of biosimilar/generic-style competition (small-molecule generics rather than biologics), balanced against manufacturing and supply-risk issues for an orphan-like product category.

What is DEFITELIO’s current market size, revenue trend, and growth drivers?

DEFITELIO is used for severe hepatic VOD and requires IV administration in hospital settings. Market outcomes are dominated by transplant center adoption, adherence to VOD diagnostic criteria, and payer reimbursement alignment for inpatient oncology/transplant drugs.

Key demand drivers

• Transplant volume and conditioning regimen intensity: higher-risk conditioning and VOD incidence lift addressable demand.
• Center protocols: adoption rises when DEFITELIO becomes embedded in VOD management pathways.
• Diagnostic timing: earlier confirmation of severe VOD increases the likelihood of treatment within windowed eligibility.
• Budget impact discipline: hospital pharmacy budgets and payer prior-authorization policies shape net sales, especially where coverage varies by region.

Key constraints on growth

• Incidence-limited indication: severe VOD is a subset of hepatic complications post-transplant.
• Inpatient-only utilization: volume growth tracks bed capacity and transplant scheduling rather than outpatient scaling.
• Conditioning shifts: use of regimens that reduce VOD incidence can compress patient counts even if transplant volumes rise.
• Reimbursement leverage: changes in oncology/transplant drug reimbursement, including bundling pressure and DRG effects, can reduce realized pricing.

Implications for financial trajectory

• Revenue typically scales with transplant volumes and center adoption rather than broad population growth.
• Financial performance is sensitive to any competitor entry into the same indication via the FDA pathway for small-molecule oral/IV therapeutics (generics or 505(b)(2) products), which would trigger price compression in a hospital drug budget context.

How strong is the DEFITELIO patent estate, and what patents protect defibrotide?

DEFITELIO is a small-molecule drug (defibrotide). Patent protection typically includes composition-of-matter and, critically for launch defense, method-of-use and specific formulation/production-related patents.

What to expect from typical DEFIBRITOTIDE/IP coverage

• Composition-of-matter patents: protect the active ingredient and core chemical identity.
• Formulation patents: protect IV formulation, concentration, excipients, stability, and manufacturing constraints.
• Method-of-use patents: cover treatment regimens for severe hepatic VOD, dosing schedules, and patient subgroups.
• Process patents: manufacturing steps that can impede “easy” generic replication.

IP monitoring priorities for investors and licensing

• Orange Book coverage breadth: number of listed patents and which ones correspond to the drug substance vs the drug product.
• Claims tied to severe hepatic VOD populations: method-of-use claims are often the most litigated in hospital niche drugs because they can deter label-expansion generics.
• Expiration dispersion: even one late-expiring patent can delay generic substitution.

When does DEFITELIO lose exclusivity and what are the key expiration milestones?

The timing of exclusivity loss drives the market’s pricing reset risk. For a niche inpatient drug, even a single late-expiring exclusivity or a hard-to-design-around method-of-use patent can extend high net pricing.

MILSTONE TYPES TO MAP

• Composition-of-matter patent expirations (primary life-cycle anchor).
• Formulation/drug-product patent expirations (often later than generic chemists expect).
• Any granted exclusivity (regulatory exclusivity can sit alongside patent expiry and delay ANDA approvals or labeling carve-outs).
• Exclusivity tied to approval under specific FDA statutes or pediatric-specific protections.

Trajectory logic

• Growth stays stable while only “skin-in-the-game” competitors are barred.
• Earnings sensitivity increases in the 12 to 36 months leading up to expiration windows due to payer and hospital procurement planning.

What is the Orange Book status of DEFITELIO?

Orange Book status determines when ANDA pathways become viable and whether existing generics can legally market with carve-outs.

What the Orange Book review typically reveals for DEFITELIO

• Patent listing count by category: drug substance, drug product, and method-of-use.
• Earliest patent expiration and latest patent expiration.
• Which patents are eligible for paragraph IV certifications.
• Whether listed patents are Orange Book “blockers” for the exact approved indication.

Why this matters financially

• If multiple method-of-use patents remain listed late, generic launches may require narrow labels or litigation-driven carve-outs, reducing near-term price pressure.

Which companies are challenging DEFITELIO with Paragraph IV ANDAs?

Paragraph IV challenges are the principal competitive catalyst for small-molecule niche hospital drugs. A pending or resolved ANDA dispute can compress pricing even before patent expiry due to settlement entry dates.

What to track

• Filed ANDAs and paragraph IV certifications against listed patents.
• Notice of FDA “intended” generic entry timelines.
• Litigation filings in the Hatch-Waxman framework.
• Settlement terms that define a delayed entry date and potential “launch at-risk” posture.

What DEFITELIO patent litigation affects generic entry risk?

Hatch-Waxman litigation drives entry timing and label scope. For hospital niche drugs, settlements often trade earlier launches for weaker positions on specific method-of-use claims.

Litigation outcomes to map

• District court rulings on claim construction and validity.
• Federal Circuit decisions, if appealed.
• Stay orders and consent decrees linking generic entry to specific dates.
• Settlement-driven covenants about labeling and marketing.

What generic entry risks exist for DEFITELIO?

Generic competition risk in this therapeutic niche depends on:

• Ability to match the IV formulation within stability and bioavailability constraints.
• Whether method-of-use patents force a label carve-out that reduces substitution.
• Litigation duration and settlement delay terms.

Commercial impact mechanics

• Once a generic launches with broad label parity, net price often drops rapidly as hospitals switch to lowest-cost options through pharmacy procurement tenders.
• If a generic enters with narrower labeling, switching can be partial, limiting margin compression.

How does DEFITELIO’s competitive landscape compare with other treatments for hepatic VOD?

DEFITELIO competes within the “hepatic VOD/SOS” treatment landscape, where standard-of-care protocols guide drug choice. Substitution can come from:

• Alternative VOD therapies in some centers or based on patient-specific contraindications.
• Off-protocol or guideline-dependent management strategies.
• Clinical pathway shifts that emphasize supportive care and risk-stratified adjuncts.

Financial implication

• Even without direct generics, shifting clinical practice can reduce market share for DEFITELIO. Competitive effect is typically slower than generic-driven pricing changes, but can be material if large transplant networks revise protocols.

What formulations are protected by DEFITELIO patents?

For IV products, formulation IP often matters as much as the molecule.

Formulation areas typically covered

• Concentration and reconstitution requirements.
• Excipients and buffer system protecting stability.
• Storage and shelf-life parameters that affect distribution.
• Manufacture and sterile filtration/production steps.

Market impact

• If formulation patents remain enforceable, generic manufacturers face higher redesign cost and longer regulatory submission cycles (including stability data).

What method-of-use patents protect DEFITELIO dosing regimens?

Method-of-use patents are commonly aligned to:

• Severe hepatic VOD diagnostic criteria.
• Treatment initiation window.
• Dosing schedule and duration.
• Use in specific transplant contexts such as pediatric and adult post HSCT.

Why it affects financial trajectory

• Generic entrants can sometimes file with modified claims or narrower labels; the commercial impact depends on whether hospital formularies can substitute under their protocol.

How does DEFITELIO compare with other transplant niche drugs on pricing and reimbursement?

Niche inpatient oncology/transplant products commonly face:

• Negotiated payer contracting with center-specific formularies.
• Reimbursement that depends on hospital billing systems and drug administration reimbursement.
• Tenders where price is prioritized after any generic substitution.

Competitive pricing pattern to expect

• Premium pricing persists while exclusivity and patent barriers remain.
• Net-to-gross often compresses during procurement cycles as competitor options increase.

How do supply chain, manufacturing scale, and procurement affect DEFITELIO sales?

A hospital IV therapy’s financial performance depends on supply reliability:

• Tight lot release schedules can limit backorders.
• IV manufacturing complexity can create capacity constraints.
• Distribution lead times affect hospital ordering.

Procurement dynamic

• Transplant centers prefer reliable suppliers; any supply interruptions can cause temporary switching to alternatives, impacting net sales.

What is the likely financial trajectory under different entry scenarios?

Scenario A: No entry near-term

• Revenue growth stays modest and tracks transplant volumes and protocol adoption.
• Margin stability is maintained due to continued branded exclusivity.

Scenario B: ANDA launch after patent/exclusivity expiry

• Net sales decline as hospitals substitute under tenders and procurement.
• Price erosion is typically swift; volume can decline if label carve-outs reduce substitution.

Scenario C: Litigation settlement enabling delayed entry

• Sales remain higher until the settlement entry date.
• After entry, price compression is similar to Scenario B, but timing is predictable and centers plan substitution earlier.

Key Takeaways

• DEFITELIO’s revenue trajectory is shaped primarily by transplant-center adoption within a narrow severe hepatic VOD patient pool.
• Financial upside is constrained by incidence and inpatient-only administration; pricing power persists only while patent and exclusivity barriers block small-molecule competition.
• The dominant competitive risk is generic-style entry once Orange Book-protected patents expire or are cleared through litigation/settlement.
• The near-to-mid-term revenue path should be modeled around (1) patent expiry dispersion, (2) Orange Book listing breadth (drug substance, drug product, and method-of-use), and (3) timing and terms of any paragraph IV challenges.

FAQs

1) What happens to DEFITELIO net pricing after generic or 505(b)(2) competition enters?
Hospital procurement typically drives rapid net price compression after label-parity competition, with partial retention only if method-of-use carve-outs limit substitution.

2) How do transplant conditioning regimen changes affect DEFITELIO demand?
Regimens that reduce VOD incidence reduce the number of eligible severe hepatic VOD cases, tightening the addressable patient pool even if transplant volumes remain stable.

3) Are method-of-use patents more important than formulation patents for DEFITELIO substitution?
Often yes for commercial substitution because hospital formularies and VOD protocols rely on label-specific eligibility; drug-product-only barriers can be less limiting if label parity is retained.

4) What legal events most influence the timing of a generic DEFITELIO launch?
Federal court validity rulings, Federal Circuit outcomes, and settlement entry dates tied to specific Orange Book patents.

5) What payer mechanisms most affect DEFITELIO realized revenue in hospitals?
Contracted hospital acquisition costs, prior authorization requirements for high-cost inpatient drugs, and tender-driven pharmacy procurement pricing.

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Approval Reports and labeling for DEFITELIO (defibrotide).

DrugChatter Q&A for DEFITELIO

Defitelio defibrotide sodium drug profile 2024 drugpatentwatch?