Generic entry timeline

ARIMOCLOMOL CITRATE generics — when can they launch?

ARIMOCLOMOL CITRATE (ARIMOCLOMOL CITRATE) · · 12 active US patents · 0 expired

Earliest patent expiry
2029-06-26
3 years remaining
Full patent estate to
2029-08-19
complete protection through 2029
FDA approval
2024

Where ARIMOCLOMOL CITRATE sits in the generic timeline

Imminent generic cliff: earliest active US patent for ARIMOCLOMOL CITRATE expires in 2029 (~3 years 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 ARIMOCLOMOL CITRATE 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-4021(no description)

Sample patent estate

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

  • US9884058 Method of Use · expires 2029-06-26
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of Hsp70 as a regulator of enzymatic activity
  • US9884058 Method of Use · expires 2029-06-26
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of Hsp70 as a regulator of enzymatic activity
  • US9884058 Method of Use · expires 2029-06-26
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of Hsp70 as a regulator of enzymatic activity
  • US9884058 Method of Use · expires 2029-06-26
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of Hsp70 as a regulator of enzymatic activity
  • US9289472 Method of Use · expires 2029-08-11
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of HSP70 as a regulator of enzymatic activity
  • US9289472 Method of Use · expires 2029-08-11
    This patent protects a method of modulating enzymatic activity by administering or inducing Hsp70 to interact with BMP.
    USPTO title: Use of HSP70 as a regulator of enzymatic activity

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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