Pizensy generics — when can they launch?
Pizensy (LACTITOL) · Braintree Labs · 1 active US patent · 0 expired
Where Pizensy sits in the generic timeline
Long-dated protection: earliest active US patent for Pizensy extends to 2037 (~11 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 — 1 patent
FDA U-codes carved out by Pizensy 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-1516 | (no description) |
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the Pizensy drug page →
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This patent protects a method of administering lactitol formulations to treat chronic idiopathic constipation by taking them after or during a meal.USPTO title: Method of administering lactitol to reduce plasma concentration of lactitol
Sources
- FDA Orange Book — patents listed against Pizensy (NDA filed 2020)
- Pizensy drug profile — full patent estate, indications, clinical trials, pricing
- Braintree Labs patent portfolio
- Patent cliff 2037 — 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.
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