Daliresp generics — when can they launch?
Daliresp (ROFLUMILAST) · Arcutis · 68 active US patents · 0 expired
Where Daliresp sits in the generic timeline
Long-dated protection: earliest active US patent for Daliresp 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.
- Formulation — 42 patents
- Method of Use — 26 patents
FDA U-codes carved out by Daliresp 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-4203 | (no description) |
U-4301 | (no description) |
U-3970 | (no description) |
U-3748 | (no description) |
U-3712 | (no description) |
U-3773 | (no description) |
Sample patent estate
Showing 6 of 68 active US patents. View full estate on the Daliresp drug page →
-
This patent protects a method of reducing gastrointestinal side effects from a PDE-4 inhibitor, such as roflumilast, by topically administering it with phosphate ester surfactants.USPTO title: Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
-
This patent protects a pharmaceutical composition that inhibits the growth of roflumilast crystals during storage by including hexylene glycol.USPTO title: Inhibition of crystal growth of roflumilast
-
This patent protects a method for reducing gastrointestinal side effects of a PDE-4 inhibitor, such as roflumilast, by topically administering it with phosphate ester surfactants.USPTO title: Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
-
This patent protects a method for reducing gastrointestinal side effects of a PDE-4 inhibitor, such as roflumilast, by topically administering it with phosphate ester surfactants.USPTO title: Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
-
This patent protects a pharmaceutical composition that inhibits the growth of roflumilast crystals during storage by including hexylene glycol.USPTO title: Inhibition of crystal growth of roflumilast
-
This patent protects a method of using roflumilast, specifically a topical formulation with certain additives to improve delivery and plasma half-life.USPTO title: Topical roflumilast formulation having improved delivery and plasma half-life
Sources
- FDA Orange Book — patents listed against Daliresp (NDA filed 2011)
- Daliresp drug profile — full patent estate, indications, clinical trials, pricing
- Arcutis 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.
Get generic entry alerts
Free Pharma CI alerts on Daliresp — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →