Cerdelga is a drug owned by Genzyme Corp. It is protected by 7 US drug patents filed from 2014 to 2022. Out of these, 4 drug patents are active and 3 have expired. Cerdelga's patents have been open to challenges since 19 August, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 13, 2038. Details of Cerdelga'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. | |||
| US11458119 | Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
Nov, 2030
(6 years from now) | Active |
| US7196205 | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Jun, 2026
(1 year, 7 months from now) | Active |
| US6916802 | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10888544 | Methods for treating Gaucher disease |
Dec, 2038
(14 years from now) | Active |
| US10888547 | Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
Jan, 2031
(6 years from now) | Active |
| US7253185 | Amino ceramide-like compounds and therapeutic methods of use |
Apr, 2022
(2 years ago) |
Expired
|
| US7615573 | Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors |
Apr, 2022
(2 years 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 Cerdelga's patents.
Latest Legal Activities on Cerdelga's Patents
Given below is the list of recent legal activities going on the following patents of Cerdelga.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jun, 2024 | US10888544 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jun, 2024 | US10888547 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Oct, 2022 | US11458119 |
| Recordation of Patent Grant Mailed Critical | 04 Oct, 2022 | US11458119 |
| Email Notification Critical | 15 Sep, 2022 | US11458119 |
| Issue Notification Mailed Critical | 14 Sep, 2022 | US11458119 |
| Mailing Corrected Notice of Allowability | 29 Jul, 2022 | US11458119 |
| Email Notification Critical | 29 Jul, 2022 | US11458119 |
| Application Is Considered Ready for Issue Critical | 28 Jul, 2022 | US11458119 |
| Dispatch to FDC | 28 Jul, 2022 | US11458119 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Cerdelga and ongoing litigations to help you estimate the early arrival of Cerdelga generic.
Cerdelga's Litigations
Cerdelga been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 05, 2019, against patent number US10888547. The petitioner , challenged the validity of this patent, with Genzyme Corporation as the respondent. Click below to track the latest information on how companies are challenging Cerdelga's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11458119 | November, 2020 |
Decision
(27 Sep, 2021) | Hanlan Liu et al. | |
| US10888547 | April, 2019 |
Decision
(30 Apr, 2020) | Genzyme Corporation | |
FDA has granted some exclusivities to Cerdelga. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cerdelga, 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 Cerdelga.
Exclusivity Information
Cerdelga holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Cerdelga's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 19, 2019 |
| Orphan Drug Exclusivity(ODE) | Aug 19, 2021 |
| Orphan Drug Exclusivity(ODE-73) | Aug 19, 2021 |
Several oppositions have been filed on Cerdelga'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 Cerdelga's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cerdelga patents.
Cerdelga's Oppositions Filed in EPO
Cerdelga has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 27, 2015, by Sandoz Ag. This opposition was filed on patent number EP10785289A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16175117A | May, 2020 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP16175117A | May, 2020 | Hetero Labs Limited | Granted and Under Opposition |
| EP16175117A | May, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP10785289A | Feb, 2015 | SANDOZ AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Cerdelga 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 Cerdelga's family patents as well as insights into ongoing legal events on those patents.
Cerdelga's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cerdelga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 13, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cerdelga Generic API suppliers:
Eliglustat Tartrate is the generic name for the brand Cerdelga. 5 different companies have already filed for the generic of Cerdelga, with Aizant having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cerdelga's generic
How can I launch a generic of Cerdelga before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cerdelga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cerdelga'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 Cerdelga -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 84 mg | 20 Aug, 2018 | 6 | 08 Sep, 2021 | 26 Jun, 2026 | Deferred |
About Cerdelga
Cerdelga is a drug owned by Genzyme Corp. It is used for long-term treatment of Gaucher disease type 1. Cerdelga uses Eliglustat Tartrate as an active ingredient. Cerdelga was launched by Genzyme Corp in 2014.
Approval Date:
Cerdelga was approved by FDA for market use on 19 August, 2014.
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 Cerdelga is 19 August, 2014, its NCE-1 date is estimated to be 19 August, 2018.
Active Ingredient:
Cerdelga uses Eliglustat Tartrate as the active ingredient. Check out other Drugs and Companies using Eliglustat Tartrate ingredient
Treatment:
Cerdelga is used for long-term treatment of Gaucher disease type 1.
Dosage:
Cerdelga is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 84MG BASE | CAPSULE | Prescription | ORAL |