---
type: entity
entity_type: company
name: Apotex Inc.
domain: health
status: active
founded: null
headquarters: Canada
website: https://www.apotex.com
tags: [generic-pharmaceuticals, semaglutide, GLP-1, biosimilar]
---

# Apotex Inc.

Canadian generic pharmaceutical manufacturer.

## Overview

Apotex is a generic pharmaceutical company that received the first US FDA tentative approval for generic semaglutide injection in partnership with Orbicular Pharmaceutical Technologies.

## Timeline

- **2026-04-10** — Received first US FDA tentative approval for generic semaglutide injection (ANDA) in partnership with Orbicular Pharmaceutical Technologies. As first ANDA filer, would receive 180 days of market exclusivity upon commercial launch. Tentative approval confirms application meets FDA standards but does not permit marketing due to Novo Nordisk patent barriers extending to December 5, 2031.

## Strategic Position

First-mover position in US generic semaglutide market with regulatory approval complete but commercial launch blocked by patent thicket. Realistic market entry: 2031-2033.