Generic entry timeline

Xdemvy generics — when can they launch?

Xdemvy (LOTILANER) · Tarsus · 9 active US patents · 0 expired

Earliest patent expiry

2030-01-17

4 years remaining

Full patent estate to

2038-12-14

complete protection through 2038

FDA approval

2023

Tarsus

Where Xdemvy sits in the generic timeline

Mid-term cliff: earliest active US patent for Xdemvy expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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 — 5 patents
Formulation — 3 patents
Composition of Matter — 1 patent

FDA U-codes carved out by Xdemvy 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-3674`	(no description)

Sample patent estate

Showing 6 of 9 active US patents. View full estate on the Xdemvy drug page →

US8383659 Composition of Matter · expires 2030-01-17

This patent protects novel isoxazoline compounds with pesticidal properties for use on non-human animals.

USPTO title: Isoxazoline derivatives as pesticides
US12213964 Formulation · expires 2038-12-14

This patent protects methods and compositions for treating or preventing ophthalmic and dermatologic conditions using isoxazoline parasiticides or formamidine parasiticides.

USPTO title: Isoxazoline parasiticide formulations
US11197847 Method of Use · expires 2038-12-14

This patent protects methods for treating or preventing ophthalmic and dermatologic conditions, including blepharitis, using an isoxazoline parasiticide or other active ingredient.

USPTO title: Isoxazoline parasiticide formulations and methods for treating blepharitis
US11752137 Formulation · expires 2038-12-14

This patent protects methods and compositions for treating or preventing ophthalmic and dermatologic conditions, including ocular surface conditions, using isoxazoline or formamidine parasiticides.

USPTO title: Ophthalmic compositions for treating ocular Demodex using lotilaner formulations
US11690827 Method of Use · expires 2038-12-14

This patent protects methods for treating or preventing ophthalmic and dermatologic conditions, including ocular surface conditions, using a specific type of medication formulation.

USPTO title: Methods for treating ocular Demodex using lotilaner formulations
US11690826 Method of Use · expires 2038-12-14

This patent protects methods for treating or preventing ophthalmic and dermatologic conditions, including blepharitis, by topically administering an effective amount of a specific active ingredient to the ocular surface.

USPTO title: Methods for treating demodex blepharitis using lotilaner formulations

Sources

FDA Orange Book — patents listed against Xdemvy (NDA filed 2023)
Xdemvy drug profile — full patent estate, indications, clinical trials, pricing
Tarsus patent portfolio
Patent cliff 2030 — 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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