BELEODAQ Drug Patent Profile
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When do Beleodaq patents expire, and when can generic versions of Beleodaq launch?
Beleodaq is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-nine patent family members in twenty-seven countries.
The generic ingredient in BELEODAQ is belinostat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the belinostat profile page.
DrugPatentWatch® Generic Entry Outlook for Beleodaq
Beleodaq was eligible for patent challenges on July 3, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 27, 2027. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for BELEODAQ
| International Patents: | 59 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 17 |
| Patent Applications: | 1,831 |
| Drug Prices: | Drug price information for BELEODAQ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BELEODAQ |
| What excipients (inactive ingredients) are in BELEODAQ? | BELEODAQ excipients list |
| DailyMed Link: | BELEODAQ at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BELEODAQ
*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 BELEODAQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Acrotech Biopharma Inc. | Phase 3 |
| University of Utah | Phase 1 |
| Mayo Clinic | Phase 1 |
Pharmacology for BELEODAQ
| Drug Class | Histone Deacetylase Inhibitor |
| Mechanism of Action | Histone Deacetylase Inhibitors |
Paragraph IV (Patent) Challenges for BELEODAQ
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BELEODAQ | Injection | belinostat | 500 mg/vial | 206256 | 1 | 2018-07-03 |
US Patents and Regulatory Information for BELEODAQ
BELEODAQ is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BELEODAQ is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BELEODAQ
Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).
Pharmaceutical formulations of HDAC inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acrotech Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Acrotech Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 BELEODAQ
When does loss-of-exclusivity occur for BELEODAQ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06245495
Patent: Pharmaceutical formulations of HDAC inhibitors
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 42527
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0610128
Patent: composição farmacêutica, bolsa de infusão intravenosa, frasco ou ampola, kit, usos de um inibidor de hdac e um ou mais de ciclodextrina, arginina e meglumina e de uma composição, e, métodos de regular a proliferação celular, inibir à progressão do ciclo celular, promover a apoptose, ou uma combinação de um ou mais destes, in vitro ou in vivo, de tratamento de uma condição mediada pela hdac, de tratamento de uma condição proliferativa e de tratamento de cáncer
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 06598
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEURS DE HDAC (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1189003
Patent: Pharmaceutical formulations of HDAC inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 2579417
Patent: Pharmaceutical formulations of HDAC inhibitors
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120341
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 12498
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 01729
Estimated Expiration: ⤷ Sign Up
Patent: 94969
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 078002
Patent: FORMULACIONES FARMACEUTICAS DE INHIBIDORES DE HDAC
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8982
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ (PHARMACEUTICAL COMPOSITIONS COMPRISING HDAC (HISTONE DEACETYLASE) INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 3400
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ (PHARMACEUTICAL FORMULATIONS COMPRISING HISTONE DEACETYLASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 0702467
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ
Estimated Expiration: ⤷ Sign Up
Patent: 1370122
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 01729
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEURS DE HDAC (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 94969
Patent: Formulations pharmaceutiques d'inhibiteurs de HDAC (Pharmaceutical formulations of HDAC inhibitors)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 10797
Patent: PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7231
Patent: הרכבים רוקחיים הכוללים מעכב היסטון דה-אצטילז וארגינין חופשי או מלח שלו, שימוש בהם ומוצרים המכילים אותם (Pharmaceutica l compositions of a histone deacetylase (hdac) inhibitor and free arginine or salt thereof' use thereof and products containing the same)
Estimated Expiration: ⤷ Sign Up
Patent: 4229
Patent: תכשיר רוקחי המכיל מעכב היסטון דה-אצטילז ומגלומין ושימוש בו ליצור תרופה (Pharmaceutical composition comprising a histone deacetylase inhibitor and meglumine and uses thereof in the manufacture of a medicament)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08750
Estimated Expiration: ⤷ Sign Up
Patent: 67068
Estimated Expiration: ⤷ Sign Up
Patent: 08540499
Estimated Expiration: ⤷ Sign Up
Patent: 12188444
Patent: PHARMACEUTICAL FORMULATION OF HDAC INHIBITOR
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07013938
Patent: FORMULACIONES FARMACEUTICAS DE INHIBIDORES DE HISTONA DESACETILASA. (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3236
Patent: Pharmaceutical formulations of N-hydroxy-3-(3-phenylsulfamoyl-phenyl)-acrylamide, aka PXD-101, and arginine
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 9954
Estimated Expiration: ⤷ Sign Up
Patent: 076366
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 01729
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 01729
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 214
Patent: FARMACEUTSKE FORMULACIJE HDAC INHIBITORA (PHARMACEUTICAL FORMAULATIONS OF HDAC INIBITORS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 01729
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0710313
Patent: Pharmaceutical formulations of HDAC inhibitors
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1329437
Estimated Expiration: ⤷ Sign Up
Patent: 1340824
Estimated Expiration: ⤷ Sign Up
Patent: 080016636
Patent: PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 130079665
Patent: PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 80887
Estimated Expiration: ⤷ Sign Up
Patent: 40204
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 810
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, КОТОРЫЕ СОДЕРЖАТ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ;ФАРМАЦЕВТИЧНІ СКЛАДИ, ЩО МІСТЯТЬ ІНГІБІТОРИ ДЕАЦЕТИЛАЗИ ГІСТОНІВ (PHARMACEUTICAL FORMULATIONS OF HISTONE DEACETYLASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
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 BELEODAQ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 224229 | תכשיר רוקחי המכיל מעכב היסטון דה-אצטילז ומגלומין ושימוש בו ליצור תרופה (Pharmaceutical composition comprising a histone deacetylase inhibitor and meglumine and uses thereof in the manufacture of a medicament) | ⤷ Sign Up |
| Australia | 9013101 | ⤷ Sign Up | |
| China | 102579417 | Pharmaceutical formulations of HDAC inhibitors | ⤷ Sign Up |
| South Korea | 20130079665 | PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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