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
Summary for BELEODAQ
| International Patents: | 59 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 16 |
| Patent Applications: | 2,383 |
| 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
Generic Entry Date for BELEODAQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;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 BELEODAQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Utah | Phase 1 |
| Mayo Clinic | Phase 1 |
| Axis Clinicals Limited | Phase 1 |
Pharmacology for BELEODAQ
| Drug Class | Histone Deacetylase Inhibitor |
| Mechanism of Action | Histone Deacetylase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BELEODAQ
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).
Pharmaceutical formulations of HDAC inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Acrotech Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 2527
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0610128
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 06598
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1189003
Estimated Expiration: ⤷ Try a Trial
Patent: 2579417
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120341
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12498
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 01729
Estimated Expiration: ⤷ Try a Trial
Patent: 94969
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 078002
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8982
Estimated Expiration: ⤷ Try a Trial
Patent: 3400
Estimated Expiration: ⤷ Try a Trial
Patent: 0702467
Estimated Expiration: ⤷ Try a Trial
Patent: 1370122
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 01729
Estimated Expiration: ⤷ Try a Trial
Patent: 94969
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 10797
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7231
Estimated Expiration: ⤷ Try a Trial
Patent: 4229
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08750
Estimated Expiration: ⤷ Try a Trial
Patent: 67068
Estimated Expiration: ⤷ Try a Trial
Patent: 08540499
Estimated Expiration: ⤷ Try a Trial
Patent: 12188444
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07013938
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3236
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 9954
Estimated Expiration: ⤷ Try a Trial
Patent: 076366
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 01729
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 01729
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 214
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 01729
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0710313
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1329437
Estimated Expiration: ⤷ Try a Trial
Patent: 1340824
Estimated Expiration: ⤷ Try a Trial
Patent: 080016636
Estimated Expiration: ⤷ Try a Trial
Patent: 130079665
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 80887
Estimated Expiration: ⤷ Try a Trial
Patent: 40204
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 810
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| European Patent Office | 2494969 | Formulations pharmaceutiques d'inhibiteurs de HDAC (Pharmaceutical formulations of HDAC inhibitors) | ⤷ Try a Trial |
| Denmark | 1901729 | ⤷ Try a Trial | |
| Japan | 2004511462 | ⤷ Try a Trial | |
| Mexico | 2007013938 | FORMULACIONES FARMACEUTICAS DE INHIBIDORES DE HISTONA DESACETILASA. (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS.) | ⤷ Try a Trial |
| Spain | 2445578 | ⤷ Try a Trial | |
| Denmark | 2494969 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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