Beleodaq is a drug owned by Acrotech Biopharma Inc. It is protected by 2 US drug patents filed in 2014 out of which none have expired yet. Beleodaq's patents have been open to challenges since 03 July, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 27, 2027. Details of Beleodaq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6888027 | Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors |
Aug, 2026
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8835501 | Pharmaceutical formulations of HDAC inhibitors |
Oct, 2027
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Beleodaq's patents.
Latest Legal Activities on Beleodaq's Patents
Given below is the list of recent legal activities going on the following patents of Beleodaq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Petition to Accept Late Payment of Maintenance Fee Payment Filed Critical | 02 Mar, 2023 | US8835501 |
| Surcharge, Petition to Accept Pymt After Exp, Unintentional Critical | 02 Mar, 2023 | US8835501 |
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 02 Mar, 2023 | US8835501 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 02 Mar, 2023 | US8835501 |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 02 Mar, 2023 | US8835501 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Mar, 2023 | US8835501 |
| Expire Patent Critical | 24 Oct, 2022 | US8835501 |
| Maintenance Fee Reminder Mailed Critical | 10 May, 2022 | US8835501 |
| Patent Term Extension Certificate Critical | 23 Aug, 2021 | US6888027 |
| Notice of Final Determination -Eligible | 25 Feb, 2021 | US6888027 |
FDA has granted several exclusivities to Beleodaq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Beleodaq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Beleodaq.
Exclusivity Information
Beleodaq holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Beleodaq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 03, 2019 |
| Orphan Drug Exclusivity(ODE) | Jul 03, 2021 |
| Orphan Drug Exclusivity(ODE-68) | Jul 03, 2021 |
US patents provide insights into the exclusivity only within the United States, but Beleodaq is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Beleodaq's family patents as well as insights into ongoing legal events on those patents.
Beleodaq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Beleodaq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 27, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Beleodaq Generics:
There are no approved generic versions for Beleodaq as of now.
How can I launch a generic of Beleodaq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Beleodaq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Beleodaq's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Beleodaq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/vial | 03 Jul, 2018 | 1 | 27 Oct, 2027 |
About Beleodaq
Beleodaq is a drug owned by Acrotech Biopharma Inc. It is used for treating relapsed or refractory peripheral T-cell lymphoma (PTCL). Beleodaq uses Belinostat as an active ingredient. Beleodaq was launched by Acrotech Biopharma in 2014.
Approval Date:
Beleodaq was approved by FDA for market use on 03 July, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Beleodaq is 03 July, 2014, its NCE-1 date is estimated to be 03 July, 2018.
Active Ingredient:
Beleodaq uses Belinostat as the active ingredient. Check out other Drugs and Companies using Belinostat ingredient
Treatment:
Beleodaq is used for treating relapsed or refractory peripheral T-cell lymphoma (PTCL).
Dosage:
Beleodaq is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/VIAL | POWDER | Prescription | INTRAVENOUS |