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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Questions you can ask:
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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 |
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
Sponsor | Phase |
---|---|
New York Medical College | Phase 2 |
Gregory Yanik | Phase 1 |
Jazz Pharmaceuticals | Phase 1 |
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
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