Glucagen generics — when can they launch?
Glucagen (GLUCAGON) · Xeris · 12 active US patents · 0 expired
Where Glucagen sits in the generic timeline
Long-dated protection: earliest active US patent for Glucagen extends to 2036 (~10 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 11 patents
- Formulation — 1 patent
FDA U-codes carved out by Glucagen 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-2604 | (no description) |
U-2742 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the Glucagen drug page →
-
This patent protects a nasal powder formulation containing glucagon or a glucagon analog for treating severe hypoglycemia.USPTO title: Nasal powder formulation for treatment of hypoglycemia
-
This patent protects a nasal powder formulation containing glucagon or a glucagon analog for treating severe hypoglycemia.USPTO title: Nasal powder formulation for treatment of hypoglycemia
-
This patent protects methods for making stable formulations of therapeutic agents, such as Glucagen, in certain solvents with added stabilizing excipients.USPTO title: Methods for producing stable therapeutic formulations in aprotic polar solvents
-
This patent protects methods for making stable formulations of therapeutic agents, such as Glucagen, in certain solvents with added stabilizing excipients.USPTO title: Methods for producing stable therapeutic formulations in aprotic polar solvents
-
This patent protects methods for making stable formulations of therapeutic agents, such as Glucagen, in certain solvents with added stabilizing excipients.USPTO title: Methods for producing stable therapeutic formulations in aprotic polar solvents
-
This patent protects methods for making stable formulations of a therapeutic glucagon agent using a specific type of solvent and excipient.USPTO title: Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
Sources
- FDA Orange Book — patents listed against Glucagen (NDA filed 1960)
- Glucagen drug profile — full patent estate, indications, clinical trials, pricing
- Xeris patent portfolio
- Patent cliff 2036 — 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 Glucagen — 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 →