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
(10 years from now) | Active |
| US9012462 | Phosphorous derivatives as kinase inhibitors |
Apr, 2031
(5 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
(8 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 19 Apr, 2022 | US9012462 |
| Notice of Final Determination -Eligible | 27 Jan, 2022 | US9012462 |
| Email Notification Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |
|---|---|---|---|
| 30MG | TABLET | Prescription | ORAL |
| 90MG | TABLET | Prescription | ORAL |
| 180MG | TABLET | Prescription | ORAL |