Levophed generics — when can they launch?
Levophed (Norepinephrine Bitartrate) · Pfizer Inc. · 36 active US patents · 0 expired
Where Levophed sits in the generic timeline
Long-dated protection: earliest active US patent for Levophed extends to 2035 (~9 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.
- Formulation — 24 patents
- Method of Use — 12 patents
FDA U-codes carved out by Levophed 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-3461 | (no description) |
U-3995 | (no description) |
Sample patent estate
Showing 6 of 36 active US patents. View full estate on the Levophed drug page →
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
-
This patent protects a formulation of a specific dosage form for the drug product Levophed.
Sources
- FDA Orange Book — patents listed against Levophed (NDA)
- Levophed drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. patent portfolio
- Patent cliff 2035 — 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 Levophed — 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 →