Macrilen Generic: When Will Generic Macimorelin 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
Macrilen Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2028 About a year and a half away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last FDA protection end? January 2030 FDA exclusivity: pediatric Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic macimorelin acetate is expected to be available in April 2028, about a year and a half away. None is for sale yet.
Why April 2028?
It is when Macrilen’s patent 8,192,719 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. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Macrilen’s last FDA protection runs to January 2030, how can a generic come sooner?
Its FDA protection (pediatric) runs to January 2030. That protection covers only the change it was granted for, such as a new strength or form, so a generic of the original version can come first. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Macrilen 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.
Macrilen by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2017 December 2017 FDA Orange Book
- Patents listed 1 last runs to April 2028 FDA Orange Book
Macrilen’s Road to a Generic
Macrilen has had the market to itself since the FDA approved it in December 2017 (Aeterna Zentaris GmbH). Its FDA protection (pediatric) runs to January 2030. Its one listed patent runs to April 2028.
The first generic of Macrilen is expected in April 2028.
Why that month: patent 8,192,719, on a way of using it, ends then.
Why a Generic Can Come Before January 2030
Its FDA protection (pediatric) runs to January 2030, but it covers only the change it was granted for, so a generic of the original version can come first. 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.
Macrilen Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Macrilen’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 8,192,719, which ends in April 2028, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,192,719 Sets the expected month of generic availability | A way of using it (U-2220) | April 2028 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-14 | Three years of protection for a change backed by new clinical studies. | July 2029 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | January 2030 | Active |
Source: FDA Orange Book, application 205598. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Macimorelin Acetate
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 company is recorded as having applied to the FDA to make a generic Macrilen yet.
Approved by the FDA
Not yet. The FDA has not approved a generic macimorelin acetate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic macimorelin acetate for sale with the FDA.
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).
Macrilen 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 Macrilen, 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.
Macrilen Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 60MG BASE/POUCH | For solution | Oral | December 2017 | Discontinued reference product |
Source: FDA Orange Book, Aeterna Zentaris GmbH. Listed for sale today by Novo Nordisk, Strongbridge U.S. Inc and Aeterna Zentaris GmbH (FDA NDC Directory).
Macrilen NDC Codes and Packages
Each Macrilen 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 |
|---|---|---|---|
| 71090-0002-02 | 60 mg/mg granule, for solution | pouch of 60 mg | Strongbridge U.S. Inc |
| 58844-0130-01 | MACIMORELIN 60 mg/1817mg granule, for solution | pouch of 60 mg | Aeterna Zentaris GmbH |
| 00169-1401-01 | MACIMORELIN 60 mg/mg granule, for solution | pouch of 60 mg | Novo Nordisk |
| 00169-1401-01 | MACIMORELIN 60 mg/mg granule, for solution | pouch of 60 mg | Novo Nordisk |
Source: the FDA NDC Directory, current listings only. Only packages sold under Macrilen’s own FDA approval (NDA 205598) are listed, never a generic. Some codes belong to companies that repackage Macrilen: it is the same medicine in a different package.
What a Generic Macrilen Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Macrilen 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 Macrilen”. 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 Macrilen
Is there a generic for Macrilen right now?
No. As of October 9, 2026 no generic macimorelin acetate is listed for sale in the FDA NDC Directory.
When will Macrilen go generic?
April 2028 is the expected month, and that is very likely but not certain. It is when Macrilen’s patent 8,192,719 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. Its FDA protection (pediatric) runs to January 2030, but it covers only the change it was granted for, so a generic of the original version can come first.
Will generic macimorelin acetate be the same as Macrilen?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Macrilen?
Not yet. The FDA Orange Book lists no approved generic version of Macrilen.
When does the Macrilen patent expire?
One patent is listed for Macrilen in the FDA Orange Book; it runs to April 2028, counting a six-month pediatric extension. The one behind the expected month is patent 8,192,719, which ends in April 2028. 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 (April 2028) weighs all of that.
Changes to This Projection
- First generic expected April 2028 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
- JevtanaCabazitaxelDuring 2026
- OnuregAzacitidine2027 to 2028
- VyondysGolodirsenJune 2028
- Spy Agent GreenIndocyanine Green2030 to 2031
- EmcitateTiratricolMarch 2034
- AsteproAzelastine HydrochlorideTBD no date yet
About Macrilen
- Generic name macimorelin acetate
- How it is taken By mouth
- Company Aeterna Zentaris GmbH
- More drugs Brand-name drugs starting with M
- Have a question? A pharmacist answers, free. Ask about Macrilen
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.