teduglutide · Takeda Pharms Usa · NDA 203441

Gattex Kit

Earliest generic entry, as listed
Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
203441 · 001 · RLDpowder, subcutaneous5MG/VIALopen
Expired or delisted (5)
  • US 7847061 · — · 1 May 2026
  • US 9060992 · — · 1 May 2026
  • US 7847061 · use U-1320 · 1 Nov 2025 · delisted
  • US 9060992 · use U-1320 · 1 Nov 2025 · delisted
  • ODE-240 · 16 May 2026