Generic entry timeline

Accutane generics — when can they launch?

Accutane (ISOTRETINOIN) · · 12 active US patents · 0 expired

Earliest patent expiry

2035-05-29

9 years remaining

Full patent estate to

2035-08-04

complete protection through 2035

FDA approval

1982

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Where Accutane sits in the generic timeline

Long-dated protection: earliest active US patent for Accutane 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 — 12 patents

Sample patent estate

Showing 6 of 12 active US patents. View full estate on the Accutane drug page →

US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin
US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin
US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin
US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin
US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin
US9750711 Formulation · expires 2035-05-29

This patent protects a low-dose oral pharmaceutical composition of isotretinoin with reduced or no food effect.

USPTO title: Low dose oral pharmaceutical composition of isotretinoin

Sources

FDA Orange Book — patents listed against Accutane (NDA filed 1982)
Accutane drug profile — full patent estate, indications, clinical trials, pricing
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.

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