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
(9 years from now) | Active |
| US11433076 | Preparation containing tetracyclic compound at high dose |
Apr, 2035
(9 years from now) | Active |
| US9365514 | Composition comprising tetracyclic compound |
Mar, 2032
(6 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 06 Sep, 2022 | US11433076 |
| Recordation of Patent Grant Mailed Critical | 06 Sep, 2022 | US11433076 |
| Email Notification Critical | 18 Aug, 2022 | US11433076 |
| Issue Notification Mailed Critical | 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 5 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 |
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
Explore Our Curated Drug Screens
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 |