Module 6

02/10/2024

Examples Expand the reach to more patients - switch from Rx to OTC

Creation of OTC formulation

• May be a good strategy to maintain or grow sales volume following Loss of Exclusivity.

Removes reimbursement hurdle

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• Nycomed registered identical dose & strength of their own product (pantoprazole)

• Introduced new, more restrictive indication

• At same time switched from prescription to non prescription (OTC) status

Day 3: OTC Switching

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

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Targeted Medicines Extending treatment to new population groups

Special populations: • Paediatrics • Elderly

Subpopulations: • New age ranges within a population e.g. neonatal

New targets: • Different phenotypes of a genetic disease • Xalkori NSCLC, ALK-positive to ROS1-positive

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

58

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