Cerdelga Generic: When Will Generic Eliglustat Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Cerdelga Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July to December 2026 A 6-month window Why then?
- Has the FDA approved a generic? September 2021 2 companies approved Why not on sale?
- When does the last patent end? December 2038 5 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic eliglustat tartrate is expected to be available between July and December 2026. None is for sale yet.
Why July to December 2026?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Cerdelga’s last patent runs to December 2038, how can a generic come sooner?
The 4 patents that run past the expected month, to December 2038 (11,458,119, 10,888,547, 12,465,586 and 10,888,544), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Cerdelga’s patents with the FDA since August 2018. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. 2 companies have held approvals since September 2021, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 6 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. See the price pattern
What should I do now?
Keep taking Cerdelga as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Cerdelga by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Very strong 6 companies have filed, 6 first in line
- Brand sales
- $226M a yearBig seller
- FDA approved 2014 August 2014 FDA Orange Book
- Patents listed 5 last runs to December 2038 A generic is expected sooner, between July and December 2026. See why FDA Orange Book
- Generics FDA-approved 2 companies, the first approved September 2021 FDA Orange Book
- Medicare Part D spent $53.2M in 2025, for 168 people CMS Part D Spending by Drug
- Medicaid prescriptions 460 in the last four reported quarters, $15.7M CMS Medicaid drug utilization, to Q1 2026
Cerdelga’s Road to a Generic
Cerdelga has had the market to itself since the FDA approved it in August 2014 (Genzyme Corp). Its 5 listed patents run to December 2038 (1 already expired). Generic companies have challenged its patents with the FDA since August 2018.
The first generic of Cerdelga is expected between July and December 2026.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before December 2038
The last listed patent runs to December 2038; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Cerdelga Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cerdelga’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,196,205 | The active ingredient | June 2026 | Expired |
| 11,458,119 | The active ingredient; the product’s formulation | November 2030 | Active |
| 10,888,547 | A way of using it (U-3042, U-3043) | January 2031 | Active |
| 12,465,586 | A way of using it (U-3042, U-3043) | June 2032 | Active |
| 10,888,544 | A way of using it (U-3041, U-3040) | December 2038 | Active |
Source: FDA Orange Book, application 205494. Patent numbers open the patent on Google Patents.
Patent Challenges to Cerdelga
The first patent challenge to Cerdelga reached the FDA in August 2018, from 6 companies on that first day. The FDA approved a first challenger’s generic in September 2021, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Cerdelga’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 84 mg | August 2018 | 6 companies | First challenger eligible decided February 2025 Earlier: decision deferred, October 2021 | September 2021 | Not yet | June 2026 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Eliglustat Tartrate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
6 companies have applied to the FDA to make generic eliglustat tartrate.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 6 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Cerdelga’s patents with the FDA since August 2018: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in September 2021. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic eliglustat tartrate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Aizant Drug Research Solutions Pvt Ltd | September 2021 | EQ 84MG BASE | AB |
| Upsher Smith Laboratories LLC | May 2023 | EQ 84MG BASE | AB |
| Teva Pharmaceuticals USA Inc discontinued | December 2021 | EQ 84MG BASE | – |
| Dr Reddys Laboratories Ltd discontinued | August 2022 | EQ 84MG BASE | – |
| Apotex Inc discontinued | July 2024 | EQ 84MG BASE | – |
| Cipla Ltd discontinued | December 2024 | EQ 84MG BASE | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Cerdelga Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Cerdelga, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Cerdelga
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Cerdelga, before manufacturer rebates.
- $14.5M
- January to March 2026, the latest CMS has posted
For 161 people, about $32,162 per prescription fill - $53.2M
- 2025, the whole year
For 168 people, about $31,240 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $14,473,051 | 161 | $32,162.34 |
| 2025 | $53,201,081 | 168 | $31,239.62 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cerdelga only, so no generic is counted in it. What CMS says it is used for: This medication is used for long-term treatment of a certain rare genetic problem (Gaucher's disease). Eliglustat works by decreasing the amount of a certain natural fatty substance (glucosylceramide) that builds up due to this condition.
Medicaid Prescriptions by Quarter
460 prescriptions in the four quarters to Q1 2026, $15.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 111 | $3,933,416 |
| Q4 2025 | 113 | $3,874,958 |
| Q3 2025 | 134 | $4,424,482 |
| Q2 2025 | 102 | $3,447,676 |
| Q1 2025 | 117 | $3,943,708 |
Source: CMS Medicaid State Drug Utilization Data, over Cerdelga’s own package codes.
Cerdelga Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 84MG BASE | Capsule | Oral | August 2014 | Prescription reference product |
Source: FDA Orange Book, Genzyme Corp. Listed for sale today by Genzyme Corporation (FDA NDC Directory).
Cerdelga NDC Codes and Packages
Each Cerdelga package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 58468-0220-01 | ELIGLUSTAT 84 mg/1 capsule | carton of 4 blister packs of 14 capsules | Genzyme Corporation |
| 58468-0220-01 | ELIGLUSTAT 84 mg/1 capsule | carton of 4 blister packs of 14 capsules | Genzyme Corporation |
| 58468-0220-02 | ELIGLUSTAT 84 mg/1 capsule | blister pack of 14 capsules | Genzyme Corporation |
| 58468-0220-02 | ELIGLUSTAT 84 mg/1 capsule | blister pack of 14 capsules | Genzyme Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cerdelga’s own FDA approval (NDA 205494) are listed, never a generic. Some codes belong to companies that repackage Cerdelga: it is the same medicine in a different package.
What a Generic Cerdelga Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cerdelga as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Cerdelga”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Cerdelga
Is there a generic for Cerdelga right now?
No. As of October 9, 2026 no generic eliglustat tartrate is listed for sale in the FDA NDC Directory. 6 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Cerdelga go generic?
July to December 2026 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to December 2038; a court ruling or a settlement can bring a generic sooner.
Will generic eliglustat tartrate be the same as Cerdelga?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 6 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Cerdelga?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in September 2021: Aizant Drug Research Solutions Pvt Ltd and Upsher Smith Laboratories LLC. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Cerdelga patent expire?
The FDA Orange Book lists 5 patents for Cerdelga; the last runs to December 2038. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (July to December 2026) weighs all of that.
Has anyone challenged the Cerdelga patents?
Yes. The first patent challenge to Cerdelga reached the FDA in August 2018, from 6 companies on that first day. The FDA approved a first challenger’s generic in September 2021, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected July to December 2026 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Arymo ERMorphine Sulfate2026 to 2027
- Spiriva RespimatTiotropium Bromide MonohydrateApril 2031
- VyndamaxTafamidisJune 2031
- Jornay PMMethylphenidate HydrochlorideMarch 2032
- EmblaveoAvibactam and AztreonamFebruary 2033
- Onzetra XsailSumatriptanOctober 2034
About Cerdelga
- Generic name eliglustat tartrate
- How it is taken By mouth
- Company Genzyme Corp
- Patent challenges Since August 2018 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cerdelga
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.