Aveed generics — when can they launch?
Aveed (TESTOSTERONE UNDECANOATE) · Marius · 61 active US patents · 3 expired
Where Aveed sits in the generic timeline
Imminent generic cliff: earliest active US patent for Aveed 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 — 48 patents
- Formulation — 10 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Aveed 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-2506 | (no description) |
U-1500 | (no description) |
U-3420 | (no description) |
U-4194 | (no description) |
U-1103 | (no description) |
U-3964 | (no description) |
Sample patent estate
Showing 6 of 61 active US patents. View full estate on the Aveed drug page →
-
This patent protects a drug delivery system for oral administration of hydrophobic drugs, including formulations of testosterone and testosterone esters.USPTO title: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
-
This patent protects a drug delivery system for oral administration of hydrophobic drugs, including formulations of testosterone and testosterone esters.USPTO title: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
-
This patent protects a drug delivery system for oral administration of hydrophobic drugs, including formulations of testosterone and testosterone esters.USPTO title: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
-
This patent protects pharmaceutical compositions, specifically injectable formulations, that contain testosterone undecanoate in a vehicle with castor oil and a co-solvent.USPTO title: Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
-
This patent protects methods for achieving prolonged, physiologically acceptable serum testosterone levels in patients deficient in endogenous testosterone.USPTO title: Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
-
This patent protects methods of treating andro- and/or testosterone deficiency in individuals by administering compositions containing testosterone and/or testosterone derivatives.USPTO title: Steroidal compositions
Sources
- FDA Orange Book — patents listed against Aveed (NDA filed 2014)
- Aveed drug profile — full patent estate, indications, clinical trials, pricing
- Marius patent portfolio
- 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 Aveed — 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 →