Generic entry timeline

THIOTEPA generics — when can they launch?

THIOTEPA (THIOTEPA) · · 4 active US patents · 0 expired

Earliest patent expiry

2037-05-31

11 years remaining

Full patent estate to

2041-08-16

complete protection through 2041

FDA approval

1959

—

Where THIOTEPA sits in the generic timeline

Long-dated protection: earliest active US patent for THIOTEPA 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 — 4 patents

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the THIOTEPA drug page →

US9931458 Formulation · expires 2037-05-31

This patent protects a method of preparing a pharmaceutical product, specifically THIOTEPA, in a single multiple chamber flexible bag.

USPTO title: Multi chamber flexible bag and methods of using same
US9931458 Formulation · expires 2037-05-31

This patent protects a method of preparing a pharmaceutical product, specifically THIOTEPA, in a single multiple chamber flexible bag.

USPTO title: Multi chamber flexible bag and methods of using same
US11975013 Formulation · expires 2041-08-16

This patent protects stable pharmaceutical compositions of thiotepa that include PEG, DMSO, and optionally water or an aqueous saline solution and thiosulfate.

USPTO title: Stable formulations comprising thiotepa
US11975013 Formulation · expires 2041-08-16

This patent protects stable pharmaceutical compositions of thiotepa with PEG, DMSO, and optional water or saline solution, and methods for treating cancer and enhancing thiotepa formulation stability.

USPTO title: Stable formulations comprising thiotepa

Sources

FDA Orange Book — patents listed against THIOTEPA (NDA filed 1959)
THIOTEPA drug profile — full patent estate, indications, clinical trials, pricing
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 THIOTEPA — 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 →