Accessible text for the Entry process flowchart, Historical Products Policy (HPP), page 3
Process
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A new generic entrant enters
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Determine the number of prior generics:
- If one prior generic, pricing category has not been established based on HPP. Price decrease is ≤10% of current generic price. Generic enters at Tier 2.
- If two prior generics, determine whether pricing category has been established based on HPP:
- If yes, price decrease is ≤30% of price established through HPP. Related generics move from Tier 2 to Tier 3.
- If no, price decrease is ≤30% of current generic price. Related generics move from Tier 2 to Tier 3.
- If 3+ prior generics, price decrease is ≤30% of current generic price. Related generics remain at Tier 3.
- If no prior generics, HPP does not apply - please refer to the TPF process for single-source generics.