Generic entry timeline

VIBEGRON generics — when can they launch?

VIBEGRON (VIBEGRON) · · 5 active US patents · 0 expired

Earliest patent expiry

2029-04-02

3 years remaining

Full patent estate to

2042-07-06

complete protection through 2042

FDA approval

2018

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Where VIBEGRON sits in the generic timeline

Imminent generic cliff: earliest active US patent for VIBEGRON expires in 2029 (~3 years 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 — 3 patents
Composition of Matter — 2 patents

FDA U-codes carved out by VIBEGRON 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-4219`	(no description)
`U-3045`	(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the VIBEGRON drug page →

US8653260 Composition of Matter · expires 2029-04-02

This patent protects compounds of Formula (I) and their use in treating or preventing diseases mediated by the activation of beta 3 adrenergic receptors.

USPTO title: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
US12180219 Composition of Matter · expires 2034-03-12

This patent protects a process for making beta-3 agonists and intermediates using ketoreductase biocatalyst enzymes.

USPTO title: Process for preparing beta 3 agonists and intermediates
US8247415 Method of Use · expires 2034-12-23

This patent protects compounds of Formula (I) and their use in treating or preventing diseases mediated by the activation of β3-adrenoceptors.

USPTO title: Hydroxymethyl pyrrolidines as Î²3 adrenergic receptor agonists
US12102638 Method of Use · expires 2040-03-22

This patent protects a method of treating overactive bladder by orally administering 60-90 mg of vibegron per day.

USPTO title: Use of vibegron to treat overactive bladder
US12357636 Method of Use · expires 2042-07-06

This patent protects a method of treating overactive bladder symptoms in men with benign prostatic hyperplasia by orally administering 60-90 mg of vibegron per day.

USPTO title: Vibegron for the treatment of overactive bladder symptoms

Sources

FDA Orange Book — patents listed against VIBEGRON (NDA filed 2018)
VIBEGRON drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2029 — 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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