Home / Generic availability / Macimorelin
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.
Patents listed with the FDA
2 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 8192719 | 2027-10-12 | method of use | MACRILEN |
| 8192719*PED | 2028-04-12 | method of use | MACRILEN |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| M-14 | 2029-07-23 | Exclusivity tied to a specific labelling or study change | MACRILEN |
| PED | 2030-01-23 | Pediatric exclusivity (adds 6 months) | MACRILEN |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| MACRILEN | Brand (NDA) | AETERNA ZENTARIS GMBH | 2017-12-20 | reference listed drug |
What a generic Macimorelin would have to match
Forms and strengths
For oral solution: 60 mg white to off-white granules in a pouch for reconstitution in 120 mL of water, resulting in a solution of 0.5 mg/mL of macimorelin. For oral solution: 60 mg ( 3 )
How it is supplied
MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution. MACRILEN is available in boxes containing 1 pouch per box (NDC 0169-1401-01). Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional [see Dosage and Administration ( 2.3 )]. Store pouches under refrigeration at 2-8°C (36-46°F). The solution must be used within 30 minutes after preparation. Discard unused portion.
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-02-18.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Setmelanotideprotection runs to October 2027
- Plecanatideprotection runs to January 2028
- Glucagonprotection runs to March 2028
- Bivalirudinprotection runs to July 2028
- Degarelixprotection runs to February 2029
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 2026-11-01. 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.
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