Opfolda Generic: When Will Generic Miglustat 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
Opfolda Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2037 About 11 years away Why then?
- Has the FDA approved a generic? April 2018 3 companies approved
- When does the last patent end? September 2038 10 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 6 companies list one
It already is. A generic miglustat is listed for sale by 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Why August 2037?
It is when Opfolda’s patent 10,857,212 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
If Opfolda’s last patent runs to September 2038, how can a generic come sooner?
The patent that runs to September 2038 (12,246,062) covers a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Opfolda, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Opfolda by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- $69M a yearSmaller seller
- FDA approved 2023 September 2023 FDA Orange Book
- Patents listed 10 last runs to September 2038 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved April 2018 FDA Orange Book
- Medicare Part D spent $58.9K in 2025, for 25 people CMS Part D Spending by Drug
Opfolda’s Road to a Generic
Opfolda has had the market to itself since the FDA approved it in September 2023 (Amicus Therapeutics US LLC). Its FDA protections on record ended by September 2026. Its 10 listed patents run to September 2038.
The first generic of Opfolda is expected in August 2037.
Why that month: patent 10,857,212, on a way of using it, ends then. That is about a year before the last listed patent runs out, in September 2038.
Why a Generic Can Come Before September 2038
The last listed patent runs to September 2038, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Opfolda Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Opfolda’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.
The one that matters for a generic launch: patent 10,857,212, which ends in August 2037, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,512,677 | A way of using it (U-3726) | March 2033 | Active |
| 11,278,599 | A way of using it (U-3726) | March 2033 | Active |
| 12,419,937 | A way of using it (U-3726) | March 2033 | Active |
| 10,208,299 | The active ingredient; the product’s formulation; a way of using it (U-3726) | September 2035 | Active |
| 10,961,522 | A way of using it (U-3726) | September 2035 | Active |
| 11,753,632 | A way of using it (U-3726) | September 2035 | Active |
| 11,278,601 | The product’s formulation; a way of using it (U-3726) | December 2036 | Active |
| 12,414,985 | A way of using it (U-3726) | December 2036 | Active |
| 10,857,212 Sets the expected month of generic availability | A way of using it (U-3726) | August 2037 | Active |
| 12,246,062 | A way of using it (U-3726) | September 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | September 2026 | Ended |
Source: FDA Orange Book, application 215211. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Miglustat
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
No application count is on record for Opfolda, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in April 2018. 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
Yes. A generic miglustat is listed for sale by 6 companies. Ask your pharmacy whether it can fill your prescription with it.
ANI Pharmaceuticals, Inc., Breckenridge Pharmaceutical, Inc., CoTherix, Inc., Edenbridge Pharmaceuticals LLC., Navinta LLC and Zydus Pharmaceuticals USA Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Ani Pharmaceuticals Inc | April 2018 | 100MG | AB |
| Edenbridge Pharmaceuticals LLC | August 2020 | 100MG | AB |
| Navinta LLC | March 2025 | 100MG | AB |
| Chartwell Rx Sciences LLC discontinued | February 2022 | 100MG | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Opfolda 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 Opfolda, 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 Opfolda
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 Opfolda, before manufacturer rebates.
- $18.7K
- January to March 2026, the latest CMS has posted
For 23 people, about $249 per prescription fill - $58.9K
- 2025, the whole year
For 25 people, about $226 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $18,702 | 23 | $249.35 |
| 2025 | $58,860 | 25 | $226.38 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Opfolda only, so no generic is counted in it. What CMS says it is used for: Miglustat is used in combination with another medication (cipaglucosidase alfa) to treat a certain inherited condition (Pompe disease). Cipaglucosidase alfa works by breaking down a certain substance (glycogen) that builds up in the body due to this condition.
Opfolda Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 65MG | Capsule | Oral | September 2023 | Prescription reference product |
Source: FDA Orange Book, Amicus Therapeutics US LLC. Listed for sale today by Amicus Therapeutics US, LLC (FDA NDC Directory).
Opfolda NDC Codes and Packages
Each Opfolda 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 |
|---|---|---|---|
| 71904-0300-01 | MIGLUSTAT 65 mg/1 capsule | bottle of 4 bottles of 1 capsule | Amicus Therapeutics US, LLC |
| 71904-0300-01 | MIGLUSTAT 65 mg/1 capsule | bottle of 4 bottles of 1 capsule | Amicus Therapeutics US, LLC |
| 71904-0300-02 | MIGLUSTAT 65 mg/1 capsule | bottle of 24 bottles of 1 capsule | Amicus Therapeutics US, LLC |
| 71904-0300-02 | MIGLUSTAT 65 mg/1 capsule | bottle of 24 bottles of 1 capsule | Amicus Therapeutics US, LLC |
| 71904-0300-03 | MIGLUSTAT 65 mg/1 capsule | bottle of 100 bottles of 1 capsule | Amicus Therapeutics US, LLC |
| 71904-0300-03 | MIGLUSTAT 65 mg/1 capsule | bottle of 100 bottles of 1 capsule | Amicus Therapeutics US, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Opfolda’s own FDA approval (NDA 215211) are listed, never a generic. Some codes belong to companies that repackage Opfolda: it is the same medicine in a different package.
What a Generic Opfolda Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Opfolda
Is there a generic for Opfolda right now?
Yes. The FDA NDC Directory lists a generic miglustat from 6 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Opfolda go generic?
It already has. The FDA NDC Directory lists a generic miglustat from 6 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic miglustat be the same as Opfolda?
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. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Opfolda?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in April 2018: Ani Pharmaceuticals Inc, Edenbridge Pharmaceuticals LLC and Navinta 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 Opfolda patent expire?
The FDA Orange Book lists 10 patents for Opfolda; the last runs to September 2038. The one behind the expected month is patent 10,857,212, which ends in August 2037. 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 month on this page (August 2037) weighs all of that.
Changes to This Projection
- First generic expected August 2037 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
- TybostCobicistat2029 to 2030
- MinocinMinocyclineDuring 2032
- QVAR RediHalerBeclomethasone Dipropionate2032 to 2033
- ZoryveRoflumilast2033 to 2034
- CobenfyTrospium Chloride and Xanomeline Tartrate2036 to 2037
- Gvoke HypoPenGlucagonApril 2036
About Opfolda
- Generic name miglustat
- How it is taken By mouth
- Company Amicus Therapeutics US LLC
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Opfolda
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, FDA NDC Directory, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.