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Last Updated: December 21, 2024

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DEFITELIO Drug Patent Profile


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When do Defitelio patents expire, and when can generic versions of Defitelio launch?

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

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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
Drug patent expirations by year for DEFITELIO
Drug Prices for DEFITELIO

See drug prices for DEFITELIO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEFITELIO
Generic Entry Date for DEFITELIO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
New York Medical CollegePhase 2
Gregory YanikPhase 1
Jazz PharmaceuticalsPhase 1

See all DEFITELIO clinical trials

US Patents and Regulatory Information for DEFITELIO

DEFITELIO is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFITELIO is ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes 11,085,043 ⤷  Subscribe Y ⤷  Subscribe
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes 11,746,348 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 12383169
Patent: Euglobulin-based method for determining the biological activity of defibrotide
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2014031934
Patent: método com base em euglobulina para determinar a atividade biológica de defibrotide
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 74960
Patent: PROCEDE A BASE D'EUGLOBULINE POUR LA DETERMINATION DE L'ACTIVITE BIOLOGIQUE DE DEFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

China

Patent: 4619857
Patent: Euglobulin-based method for determining the biological activity of defibrotide
Estimated Expiration: ⤷  Subscribe

Patent: 0079580
Patent: 用于测定去纤维蛋白多核苷酸的生物活性的基于优球蛋白的方法 (Euglobulin-based method used for measuring biological activity of dcfibrotide)
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 64496
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 64496
Patent: PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 08503
Patent: 用於測定去纖維蛋白多核苷酸的生物活性的基於優球蛋白的方法 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

India

Patent: 584DEN2014
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6132
Patent: שיטה מבוססת-יוגלובולין לקביעת הפעילות הביולוגית של דפיברוטיד (Euglobulin-based method for determining the biological activity of defibrotide)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 98821
Estimated Expiration: ⤷  Subscribe

Patent: 15521477
Patent: デフィブロチドの生物学的活性を決定する為の、ユーグロブリンに基づく方法
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 2085
Patent: MÉTODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLÓGICA DE DEFIBRÓTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.)
Estimated Expiration: ⤷  Subscribe

Patent: 14016114
Patent: METODO A BASE DE EUGLOBULINA PARA DETERMINAR LA ACTIVIDAD BIOLOGICA DE DEFIBROTIDO. (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE.)
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 27177
Patent: СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА (METHOD FOR DEFIBROTIDE BIOLOGICAL ACTIVITY DETERMINATION, BASED ON EUGLOBULIN APPLICATION)
Estimated Expiration: ⤷  Subscribe

Patent: 14149089
Patent: СПОСОБ ОПРЕДЕЛЕНИЯ БИОЛОГИЧЕСКОЙ АКТИВНОСТИ ДЕФИБРОТИДА, ОСНОВАННЫЙ НА ПРИМЕНЕНИИ ЭУГЛОБУЛИНА
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201408481U
Patent: EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1948243
Estimated Expiration: ⤷  Subscribe

Patent: 2038357
Estimated Expiration: ⤷  Subscribe

Patent: 150044877
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

Patent: 180098420
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

Patent: 190016148
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

Patent: 190112197
Patent: 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 60969
Estimated Expiration: ⤷  Subscribe

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 ⤷  Subscribe
South Korea 101948243 ⤷  Subscribe
South Korea 20190112197 디파이브로타이드의 생물학적 활성 측정을 위한 유우글로불린에 기초한 방법 (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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

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