MACIMORELIN ACETATE generics — when can they launch?
MACIMORELIN ACETATE (MACIMORELIN ACETATE) · · 1 active US patent · 0 expired
Where MACIMORELIN ACETATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for MACIMORELIN ACETATE expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 1 patent
FDA U-codes carved out by MACIMORELIN ACETATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2220 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the MACIMORELIN ACETATE drug page →
-
This patent protects a method for diagnosing growth hormone deficiency in humans or animals by orally administering EP 1572 or EP 1573 and measuring growth hormone levels.USPTO title: Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Sources
- FDA Orange Book — patents listed against MACIMORELIN ACETATE (NDA filed 2017)
- MACIMORELIN ACETATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on MACIMORELIN ACETATE — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →