DIFELIKEFALIN ACETATE generics — when can they launch?
DIFELIKEFALIN ACETATE (DIFELIKEFALIN ACETATE) · · 12 active US patents · 0 expired
Where DIFELIKEFALIN ACETATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for DIFELIKEFALIN ACETATE expires in 2027 (~1 year 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 — 12 patents
FDA U-codes carved out by DIFELIKEFALIN ACETATE 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-3204 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the DIFELIKEFALIN ACETATE drug page →
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This patent protects synthetic peptide amide ligands that act as kappa opioid receptor agonists with low P 450 CYP inhibition and low brain penetration.USPTO title: Synthetic peptide amides
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This patent protects synthetic peptide amide ligands that act as kappa opioid receptor agonists for treating pain and inflammation associated with various diseases.USPTO title: Synthetic peptide amides
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This patent protects synthetic peptide amides that act as kappa opioid receptor agonists, useful in treating pain and inflammation associated with various diseases and conditions.USPTO title: Synthetic peptide amides
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This patent protects synthetic peptide amide ligands that activate the kappa opioid receptor with low potential for brain penetration and liver enzyme inhibition.USPTO title: Synthetic peptide amides and dimers thereof
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This patent protects synthetic peptide amides that are kappa opioid receptor agonists with low P 450 CYP inhibition and low brain penetration.USPTO title: Synthetic peptide amides and dimeric forms thereof
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This patent protects synthetic tetrapeptide amide ligands that act as kappa opioid receptor agonists, useful in treating pain and inflammation.USPTO title: Synthetic peptide amides
Sources
- FDA Orange Book — patents listed against DIFELIKEFALIN ACETATE (NDA filed 2021)
- DIFELIKEFALIN ACETATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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