Elelyso Patent Expiration

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

(9 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

(9 months from now)

Active
US8227230 Human lysosomal proteins from plant cell culture
Feb, 2024

(9 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.

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

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 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 29 Jul, 2014 US8790641
Recordation of Patent Grant Mailed 29 Jul, 2014 US8790641
Issue Notification Mailed 09 Jul, 2014 US8790641
Dispatch to FDC 26 Jun, 2014 US8790641
Application Is Considered Ready for Issue 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

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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


Family Patents

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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)