Beleodaq Patent Expiration

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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6888027 Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Aug, 2026

(2 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835501 Pharmaceutical formulations of HDAC inhibitors
Oct, 2027

(3 years from now)

Active


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

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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

Beleodaq has patent protection in a total of 27 countries. It's US patent count contributes only to 23.1% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Beleodaq.

Family Patents

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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.

Market Authorisation Date:

Beleodaq was approved by FDA for market use on 03 July, 2014.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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