Alunbrig Patent Expiration

Alunbrig is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 4 US drug patents filed from 2017 to 2019 out of which none have expired yet. Alunbrig's patents have been open to challenges since 28 April, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 10, 2035. Details of Alunbrig'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.
US10385078 Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine
Nov, 2035

(11 years from now)

Active
US9012462 Phosphorous derivatives as kinase inhibitors
Apr, 2031

(6 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9611283 Methods for inhibiting cell proliferation in ALK-driven cancers
Apr, 2034

(9 years from now)

Active
US9273077 Phosphorus derivatives as kinase inhibitors
May, 2029

(4 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 Alunbrig's patents.

Given below is the list of recent legal activities going on the following patents of Alunbrig.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 23 Aug, 2023 US9273077
Payment of Maintenance Fee, 4th Year, Large Entity 21 Jan, 2023 US10385078
Payment of Maintenance Fee, 8th Year, Large Entity 20 Sep, 2022 US9012462
Patent Term Extension Certificate 19 Apr, 2022 US9012462
Notice of Final Determination -Eligible 27 Jan, 2022 US9012462
Email Notification 25 Mar, 2021 US10385078
Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue 24 Mar, 2021 US10385078
Mail Pet Dec Routed to Certificate of Corrections Branch 24 Mar, 2021 US10385078
Pet Dec Routed to Certificate of Corrections Branch 23 Mar, 2021 US10385078
Adjustment of PTA Calculation by PTO 23 Mar, 2021 US10385078


FDA has granted several exclusivities to Alunbrig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Alunbrig, 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 Alunbrig.

Exclusivity Information

Alunbrig holds 5 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Alunbrig's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 28, 2022
New Indication(I-847) May 22, 2023
Orphan Drug Exclusivity(ODE) Apr 28, 2024
Orphan Drug Exclusivity(ODE-142) Apr 28, 2024
Orphan Drug Exclusivity(ODE-300) May 22, 2027

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Alunbrig's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Alunbrig's generic, the next section provides detailed information on ongoing and past EP oppositions related to Alunbrig patents.

Alunbrig's Oppositions Filed in EPO

Alunbrig has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 05, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP09751617A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP09751617A Jun, 2018 Generics (UK) Ltd Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Alunbrig 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 Alunbrig's family patents as well as insights into ongoing legal events on those patents.

Alunbrig's Family Patents

Alunbrig has patent protection in a total of 37 countries. It's US patent count contributes only to 23.4% 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 Alunbrig.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Alunbrig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 10, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Alunbrig Generics:

There are no approved generic versions for Alunbrig as of now.





About Alunbrig

Alunbrig is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Alunbrig uses Brigatinib as an active ingredient. Alunbrig was launched by Takeda Pharms Usa in 2017.

Approval Date:

Alunbrig was approved by FDA for market use on 28 April, 2017.

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 Alunbrig is 28 April, 2017, its NCE-1 date is estimated to be 28 April, 2021.

Active Ingredient:

Alunbrig uses Brigatinib as the active ingredient. Check out other Drugs and Companies using Brigatinib ingredient

Treatment:

Alunbrig is used for treating anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).

Dosage:

Alunbrig is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
180MG TABLET Prescription ORAL
90MG TABLET Prescription ORAL
30MG TABLET Prescription ORAL