Generic entry timeline

CETIRIZINE HYDROCHLORIDE generics — when can they launch?

CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) · · 11 active US patents · 0 expired

Earliest patent expiry
2030-02-11
4 years remaining
Full patent estate to
2033-01-09
complete protection through 2033
FDA approval
1995
—

Where CETIRIZINE HYDROCHLORIDE sits in the generic timeline

Mid-term cliff: earliest active US patent for CETIRIZINE HYDROCHLORIDE 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 — 7 patents
  • Formulation — 2 patents
  • Other — 2 patents

FDA U-codes carved out by CETIRIZINE 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-2635(no description)
U-2636(no description)
U-2634(no description)
U-1680(no description)

Sample patent estate

Showing 6 of 11 active US patents. View full estate on the CETIRIZINE HYDROCHLORIDE drug page →

  • US9180090 Method of Use · expires 2030-02-11
    This patent protects injectable formulations of cetirizine hydrochloride for treating acute allergic reactions and methods for administering them.
    USPTO title: Non-sedating antihistamine injection formulations and methods of use thereof
  • US8513259 Method of Use · expires 2030-02-11
    This patent protects injectable formulations of non-sedating antihistamines, such as cetirizine, and methods for using them to treat acute urticaria or angioedema.
    USPTO title: Non-sedating antihistamine injection formulations and methods of use thereof
  • US9119771 Method of Use · expires 2030-02-11
    This patent protects injectable formulations of non-sedating antihistamines, such as cetirizine hydrochloride, and methods of using them to treat acute allergic reactions.
    USPTO title: Non-sedating antihistamine injection formulations and methods of use thereof
  • US8263581 Method of Use · expires 2030-02-28
    This patent protects injectable formulations of non-sedating antihistamines, such as cetirizine hydrochloride, and methods of using them to treat acute allergic reactions.
    USPTO title: Non-sedating antihistamine injection formulations and methods of use thereof
  • US8314083 Method of Use · expires 2030-02-28
    This patent protects injectable formulations of cetirizine hydrochloride for treating acute allergic reactions and methods for using them.
    USPTO title: Non-sedating antihistamine injection formulations and methods of use thereof
  • US8829005 Method of Use · expires 2030-03-15
    This patent protects stable topical formulations of cetirizine hydrochloride for treating allergic conjunctivitis and/or allergic rhinoconjunctivitis by direct eye application.
    USPTO title: Ophthalmic formulations of cetirizine and methods of use

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.

Get generic entry alerts

Free Pharma CI alerts on CETIRIZINE HYDROCHLORIDE — 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 →