Spring Intro 2023

16/02/2023

Hitting Day 1 Launch is Critical for Generics

Key goal is to launch on Day 1

90% reduction in price in “mature” INN markets is normal and can happen on Day 1 of patent expiry

Development timelines are driven by regulatory and IP considerations which dictate when we can submit and launch a generic.

The Organisation for Professionals in Regulatory Affairs

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Data Exclusivity – Determines Submission Date

Article 10(1), Directive 2001/83/EC: …the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community …

• Prevents any cross-reference to that data for 8 years • Also needs to be respected by the innovator • Also covers any data available in the public domain

The Organisation for Professionals in Regulatory Affairs

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