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Home / Generic availability / Macimorelin

FDA Orange Book · updated 2026-09-23

When will generic Macimorelin be available?

Under patent or exclusivity

Based on the patents and exclusivity the FDA lists today, generic macimorelin cannot be marketed in the United States before 2030-01-23, when the last listed protection expires.

2030-01-23
Last protection expires
2
Patents listed
2
Exclusivity records
0
Generics waiting

Patents listed with the FDA

2 unexpired or current listing(s).

PatentExpiresCoversProduct
81927192027-10-12method of useMACRILEN
8192719*PED2028-04-12method of useMACRILEN

FDA exclusivity

Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.

CodeExpiresWhat it isProduct
M-142029-07-23Exclusivity tied to a specific labelling or study changeMACRILEN
PED2030-01-23Pediatric exclusivity (adds 6 months)MACRILEN

Approved products

ProductTypeApplicantApproved
MACRILENBrand (NDA)AETERNA ZENTARIS GMBH2017-12-20reference listed drug
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

Frequently asked questions

When will generic Macimorelin be available?

Based on the patents and exclusivity the FDA lists today, generic macimorelin cannot be marketed in the United States before 2030-01-23, when the last listed protection expires.

Does this date guarantee a generic launches then?

No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.

What is the difference between a patent and exclusivity?

A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.

What is a tentative approval?

It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.

Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.