FAQs Patent Questions

Question:How long is exclusivity granted for?

Answer:
It depends on what type of exclusivity is granted. Orphan Drug (ODE) - 7 years New Chemical (NCE)- 5 years "Other" Exclusivity - 3 years for a "change" if criteria are met Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

Question:All submitted drawings must be drawn on strong, white, smooth, non-shiny paper

Answer:
Drawings submitted to the Office must be made on paper which is flexible, strong, white, smooth, non-shiny, and durable. All sheets must be reasonably free from cracks, creases, and folds. Only one side of the sheet may be used for the drawing.

Question:When is a patent extension application submitted and where is it submitted?

Answer:
Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially marketed at that time.

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