Alecensa Patent Expiration

Alecensa is a drug owned by Hoffmann-la Roche Inc. It is protected by 5 US drug patents filed from 2015 to 2022 out of which none have expired yet. Alecensa's patents have been open to challenges since 12 December, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 24, 2035. Details of Alecensa'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.
US9126931 Tetracyclic compound
May, 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).
US10350214 Preparation containing tetracyclic compound at high dose
Apr, 2035

(10 years from now)

Active
US11433076 Preparation containing tetracyclic compound at high dose
Apr, 2035

(10 years from now)

Active
US9365514 Composition comprising tetracyclic compound
Mar, 2032

(7 years from now)

Active
US9440922 Tetracyclic compound
Jun, 2030

(5 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 Alecensa's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 28 Feb, 2024 US9440922
Payment of Maintenance Fee, 8th Year, Large Entity 29 Nov, 2023 US9365514
Payment of Maintenance Fee, 8th Year, Large Entity 02 Mar, 2023 US9126931
Payment of Maintenance Fee, 4th Year, Large Entity 06 Jan, 2023 US10350214
Patent Issue Date Used in PTA Calculation 06 Sep, 2022 US11433076
Recordation of Patent Grant Mailed 06 Sep, 2022 US11433076
Email Notification 18 Aug, 2022 US11433076
Issue Notification Mailed 17 Aug, 2022 US11433076
Dispatch to FDC 05 Aug, 2022 US11433076
Mailing Corrected Notice of Allowability 03 Aug, 2022 US11433076


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

Exclusivity Information

Alecensa holds 7 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Alecensa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-756) Nov 06, 2020
New Chemical Entity Exclusivity(NCE) Dec 11, 2020
Orphan Drug Exclusivity(ODE-105) Dec 11, 2022
Orphan Drug Exclusivity(ODE) Nov 06, 2024
Orphan Drug Exclusivity(ODE-159) Nov 06, 2024
New Indication(I-947) Apr 18, 2027
Orphan Drug Exclusivity(ODE-477) Apr 18, 2031

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

Alecensa's Family Patents

Alecensa has patent protection in a total of 38 countries. It's US patent count contributes only to 12.5% of its total global patent coverage. 4 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 Alecensa.

Family Patents

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Generic Launch

Generic Release Date:

Alecensa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 24, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Alecensa Generics:

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

How can I launch a generic of Alecensa before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Alecensa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Alecensa'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 Alecensa -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
150 mg 11 Dec, 2019 1 04 Mar, 2032





About Alecensa

Alecensa is a drug owned by Hoffmann-La Roche Inc. Alecensa uses Alectinib Hydrochloride as an active ingredient. Alecensa was launched by Hoffmann-La Roche in 2015.

Approval Date:

Alecensa was approved by FDA for market use on 11 December, 2015.

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 Alecensa is 11 December, 2015, its NCE-1 date is estimated to be 12 December, 2019.

Active Ingredient:

Alecensa uses Alectinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Alectinib Hydrochloride ingredient

Dosage:

Alecensa is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 150MG BASE CAPSULE Prescription ORAL