Generic entry timeline

ISOPROPYL ALCOHOL generics — when can they launch?

ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) · · 5 active US patents · 0 expired

Earliest patent expiry

2028-05-23

2 years remaining

Full patent estate to

2036-04-24

complete protection through 2036

FDA approval

2000

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Where ISOPROPYL ALCOHOL sits in the generic timeline

Imminent generic cliff: earliest active US patent for ISOPROPYL ALCOHOL expires in 2028 (~2 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 — 4 patents
Formulation — 1 patent

FDA U-codes carved out by ISOPROPYL ALCOHOL 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-1397`	(no description)

Sample patent estate

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

US9629368 Method of Use · expires 2028-05-23

This patent protects compositions and methods for using antimicrobial therapy as topical disinfectants, including compositions with paraben, redox compound, and organic acid.

USPTO title: Antimicrobial compositions and methods of use
US8703828 Formulation · expires 2028-05-23

This patent protects an antimicrobial composition containing at least one paraben, a redox compound, and an organic acid, used as a topical disinfectant.

USPTO title: Antimicrobial compositions and methods of use
US8389583 Method of Use · expires 2029-08-09

This patent protects compositions and methods for using antimicrobial therapy as topical disinfectants, including compositions with paraben, redox compound, and organic acid.

USPTO title: Antimicrobial compositions and methods of use
US10688291 Method of Use · expires 2034-12-20

This patent protects a medical skin applicator apparatus and methods for using it to store and dispense solutions to a subject's surface.

USPTO title: Medical skin applicator apparatus
US9844654 Method of Use · expires 2036-04-24

This patent protects a medical skin applicator apparatus and methods for using it to store and dispense solutions to a subject's surface.

USPTO title: Medical skin applicator apparatus

Sources

FDA Orange Book — patents listed against ISOPROPYL ALCOHOL (NDA filed 2000)
ISOPROPYL ALCOHOL drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2028 — 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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