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The market is projected to reach USD 1,426.6 million by 2035
Qualifying reasons under 503A include: Allergy to phenol or another preservative in the commercial formulation Need for a dose strength not commercially available (e.g., 1.5 mg, which falls between Ozempic's 1 mg and 2 mg pens) Inability to use the pen injector device due to dexterity issues (though this is weak because vial-and-syringe versions could theoretically be requested from Novo Nordisk) The FDA has historically taken a narrow view of what constitutes a legitimate patient-specific need, and "I prefer the compounded version" or "the commercial version is too expensive" do not qualify
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