Generic entry timeline

PASIREOTIDE PAMOATE generics — when can they launch?

PASIREOTIDE PAMOATE (PASIREOTIDE PAMOATE) · · 15 active US patents · 0 expired

Earliest patent expiry

2026-10-25

expired

Full patent estate to

2028-05-23

complete protection through 2028

FDA approval

2014

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Where PASIREOTIDE PAMOATE sits in the generic timeline

All listed Orange Book patents for PASIREOTIDE PAMOATE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

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 — 10 patents
Composition of Matter — 5 patents

Sample patent estate

Showing 6 of 15 active US patents. View full estate on the PASIREOTIDE PAMOATE drug page →

US7759308 Formulation · expires 2026-10-25

This patent protects microparticles containing a somatostatin analogue embedded in a biocompatible polymer matrix for long-acting release.

USPTO title: Microparticles comprising somatostatin analogues
US7759308 Formulation · expires 2026-10-25

This patent protects microparticles containing a somatostatin analogue embedded in a biocompatible polymer matrix for long-acting release.

USPTO title: Microparticles comprising somatostatin analogues
US7759308 Formulation · expires 2026-10-25

This patent protects microparticles containing a somatostatin analogue embedded in a biocompatible polymer matrix for long-acting release.

USPTO title: Microparticles comprising somatostatin analogues
US7759308 Formulation · expires 2026-10-25

This patent protects microparticles containing a somatostatin analogue embedded in a biocompatible polymer matrix for long-acting release.

USPTO title: Microparticles comprising somatostatin analogues
US7759308 Formulation · expires 2026-10-25

This patent protects microparticles containing a somatostatin analogue embedded in a biocompatible polymer matrix for long-acting release.

USPTO title: Microparticles comprising somatostatin analogues
US7473761 Composition of Matter · expires 2026-12-14

This patent protects a specific somatostatin analogue, cyclo[{4-(NH 2 âC 2 H 4 âNHâCOâOâ)Pro}-Phg-DTrp-Lys-Tyr(4-Benzyl)-Phe], and its pharmaceutically acceptable salts or complexes.

USPTO title: Somatostatin analogues

Sources

FDA Orange Book — patents listed against PASIREOTIDE PAMOATE (NDA filed 2014)
PASIREOTIDE PAMOATE drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2026 — 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.

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