Elelyso is a drug owned by Pfizer Inc. It is protected by 3 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 2 have expired. Elelyso's patents have been open to challenges since 01 May, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 18, 2025. Details of Elelyso'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. | |||
| US8741620 | Human lysosomal proteins from plant cell culture |
Feb, 2024
(8 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8790641 | Production of high mannose proteins in plant culture and therapeutic uses thereof |
Oct, 2025
(11 months from now) | Active |
| US8227230 | Human lysosomal proteins from plant cell culture |
Feb, 2024
(8 months ago) |
Expired
|
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 Elelyso's patents.
Latest Legal Activities on Elelyso's Patents
Given below is the list of recent legal activities going on the following patents of Elelyso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 11 Mar, 2024 | US8227230 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jan, 2022 | US8790641 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Nov, 2019 | US8227230 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jan, 2018 | US8790641 |
| Sequence Moved to Public Database | 08 Aug, 2014 | US8790641 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Jul, 2014 | US8790641 |
| Recordation of Patent Grant Mailed Critical | 29 Jul, 2014 | US8790641 |
| Issue Notification Mailed Critical | 09 Jul, 2014 | US8790641 |
| Dispatch to FDC | 26 Jun, 2014 | US8790641 |
| Application Is Considered Ready for Issue Critical | 02 Jun, 2014 | US8790641 |
FDA has granted several exclusivities to Elelyso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Elelyso, 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 Elelyso.
Exclusivity Information
Elelyso holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Elelyso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 01, 2017 |
| New Patient Population(NPP) | Aug 27, 2017 |
US patents provide insights into the exclusivity only within the United States, but Elelyso 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 Elelyso's family patents as well as insights into ongoing legal events on those patents.
Elelyso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Elelyso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 18, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Elelyso Generics:
There are no approved generic versions for Elelyso as of now.
About Elelyso
Elelyso is a drug owned by Pfizer Inc. It is used for treating Gaucher disease. Elelyso uses Taliglucerase Alfa as an active ingredient. Elelyso was launched by Pfizer in 2012.
Approval Date:
Elelyso was approved by FDA for market use on 01 May, 2012.
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 Elelyso is 01 May, 2012, its NCE-1 date is estimated to be 01 May, 2016.
Active Ingredient:
Elelyso uses Taliglucerase Alfa as the active ingredient. Check out other Drugs and Companies using Taliglucerase Alfa ingredient
Treatment:
Elelyso is used for treating Gaucher disease.
Dosage:
Elelyso is available in powder form for iv (infusion) use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200 UNITS/VIAL | POWDER | Prescription | IV (INFUSION) |