Generic entry timeline

DEXMEDETOMIDINE HYDROCHLORIDE generics — when can they launch?

DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE) · · 70 active US patents · 0 expired

Earliest patent expiry
2032-01-04
6 years remaining
Full patent estate to
2043-01-12
complete protection through 2043
FDA approval
1999
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Where DEXMEDETOMIDINE HYDROCHLORIDE sits in the generic timeline

Mid-term cliff: earliest active US patent for DEXMEDETOMIDINE HYDROCHLORIDE expires in 2032 (~6 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 — 29 patents
  • Formulation — 23 patents
  • Other — 18 patents

FDA U-codes carved out by DEXMEDETOMIDINE HYDROCHLORIDE 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-codeDescription
U-421(no description)
U-3698(no description)
U-3756(no description)
U-3645(no description)
U-3350(no description)
U-3935(no description)
U-4029(no description)
U-3725(no description)
U-3986(no description)

Sample patent estate

Showing 6 of 70 active US patents. View full estate on the DEXMEDETOMIDINE HYDROCHLORIDE drug page →

  • US9320712 Formulation · expires 2032-01-04
    This patent protects a premixed liquid formulation of dexmedetomidine hydrochloride for parenteral administration.
    USPTO title: Dexmedetomidine premix formulation
  • US8338470 Formulation · expires 2032-01-04
    This patent protects a premixed liquid formulation of dexmedetomidine hydrochloride for parenteral administration.
    USPTO title: Dexmedetomidine premix formulation
  • US8242158 Formulation · expires 2032-01-04
    This patent protects a premixed liquid formulation of dexmedetomidine hydrochloride for parenteral administration.
    USPTO title: Dexmedetomidine premix formulation
  • US8455527 Method of Use · expires 2032-01-04
    This patent protects methods of treatment using a premixed formulation of dexmedetomidine for parenteral administration in perioperative care or sedation.
    USPTO title: Methods of treatment using a dexmedetomidine premix formulation
  • US9616049 Formulation · expires 2032-01-04
    This patent protects a premixed liquid formulation of dexmedetomidine hydrochloride for parenteral administration.
    USPTO title: Dexmedetomidine premix formulation
  • US8455527 Method of Use · expires 2032-01-04
    This patent protects methods of treatment using a premixed formulation of dexmedetomidine for parenteral administration in perioperative care or sedation.
    USPTO title: Methods of treatment using a dexmedetomidine premix formulation

Sources

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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