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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 three patents protecting this drug.

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.

Indicators of Generic Entry

Summary for DEFITELIO

International Patents:	25
US Patents:	3
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

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

US Patents and Regulatory Information for DEFITELIO

DEFITELIO is protected by three US patents.

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
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes			Y
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes			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
China	104619857	Euglobulin-based method for determining the biological activity of defibrotide
South Korea	101948243
South Korea	20190112197	디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
European Patent Office	2864496	PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)

DEFITELIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DEFITELIO

Introduction to DEFITELIO

DEFITELIO, also known as defibrotide sodium, is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT)[1][4][5].

Market Need and Demand

Hepatic VOD is a life-threatening condition with high mortality rates, often exceeding 80% when associated with multi-organ dysfunction. The lack of approved therapies for this condition prior to DEFITELIO's approval created a significant unmet medical need. The drug's approval has filled this gap, providing a crucial treatment option for patients with this severe condition[1][4][5].

Clinical Trials and Efficacy

The efficacy of DEFITELIO was established through three clinical trials involving 528 patients. These trials demonstrated that 38% to 45% of patients treated with DEFITELIO survived 100 days after HSCT, significantly higher than the 21% to 31% survival rate for patients receiving supportive care or other interventions[1][4][5].

Market Growth and Projections

The defibrotide market, which includes DEFITELIO, has experienced rapid growth in recent years and is anticipated to continue this trend. Projections indicate that the market will expand significantly from 2023 to 2031, driven by the increasing demand for effective treatments for VOD and other related conditions[3].

Financial Performance of Jazz Pharmaceuticals

DEFITELIO is a key product for Jazz Pharmaceuticals, Inc., which has reported strong financial performance driven in part by the sales of this drug. In the third quarter of 2024, Jazz Pharmaceuticals exceeded revenue expectations, with DEFITELIO contributing to the company's robust financial results along with other key products like Xywav, Epidiolex, and Zepzelca[2].

Revenue Impact and Market Position

The strong sales of DEFITELIO have bolstered Jazz Pharmaceuticals' market position, particularly in the segment of treatments for rare and severe conditions. The company's consistent revenue projections and anticipated pipeline developments, including the potential approval of new treatments, further support its financial outlook[2].

Competitive Landscape

As the sole provider of an approved treatment for hepatic VOD with renal or pulmonary dysfunction following HSCT, Jazz Pharmaceuticals holds a unique market position. This exclusivity, coupled with the drug's proven efficacy, has contributed to its strong market performance and is expected to continue driving revenue growth[1][4][5].

Safety and Adverse Reactions

While DEFITELIO has shown a reasonable safety profile, it is associated with several adverse reactions, including hypotension, diarrhea, vomiting, nausea, and epistaxis. The use of DEFITELIO is contraindicated in patients being treated concurrently with anticoagulants or fibrinolytic therapies due to the risk of hemorrhage and hypersensitivity reactions[1][4].

Regulatory History and Approvals

DEFITELIO received FDA approval in 2016 after a complex regulatory journey that included initial marketing authorizations in Italy and later in Europe. The drug was granted Priority Review by the FDA, highlighting its importance in addressing a serious unmet medical need[4][5].

Analyst Ratings and Outlook

Analysts have maintained a positive outlook on Jazz Pharmaceuticals, driven by the company's strong financial performance and promising pipeline. The inclusion of DEFITELIO in this positive assessment underscores the drug's significant contribution to the company's financial health and market position[2].

Key Takeaways

• Market Need: DEFITELIO addresses a critical unmet medical need for treating hepatic VOD with renal or pulmonary dysfunction.
• Efficacy: Clinical trials have shown significant survival benefits for patients treated with DEFITELIO.
• Market Growth: The defibrotide market is projected to grow substantially from 2023 to 2031.
• Financial Performance: Strong sales of DEFITELIO have contributed to Jazz Pharmaceuticals' robust financial results.
• Competitive Position: As the sole approved treatment for this condition, DEFITELIO holds a unique market position.
• Safety Profile: While effective, DEFITELIO is associated with several adverse reactions and contraindications.

FAQs

Q: What is DEFITELIO used for? A: DEFITELIO is used for the treatment of hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT)[1][4].

Q: How is DEFITELIO administered? A: DEFITELIO is administered intravenously every 6 hours as a 2-hour infusion for at least 21 days, and continued until VOD resolution or up to 60 days of treatment[1][4].

Q: What are the survival rates for patients treated with DEFITELIO? A: Clinical trials have shown that 38% to 45% of patients treated with DEFITELIO survived 100 days after HSCT, compared to 21% to 31% for those receiving supportive care or other interventions[1][4][5].

Q: What are the common adverse reactions associated with DEFITELIO? A: Common adverse reactions include hypotension, diarrhea, vomiting, nausea, and epistaxis. Serious adverse reactions can include hemorrhage and hypersensitivity reactions[1][4].

Q: How has DEFITELIO impacted Jazz Pharmaceuticals' financial performance? A: DEFITELIO has contributed significantly to Jazz Pharmaceuticals' strong financial results, particularly in the third quarter of 2024, along with other key products[2].

Sources

1. FDA: Drug Trials Snapshots: DEFITELIO - FDA
2. Markets Business Insider: Jazz Pharmaceuticals: Strong Financial Performance and Promising Pipeline Justify Buy Rating
3. Market Research Intellect: Global Defibrotide Market Size, Scope And Forecast Report
4. FDA: Defitelio (defibrotide sodium) - FDA
5. FDA: 208114Orig1s000 - accessdata.fda.gov