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:What is a regulatory review period determination?

Answer:
The regulatory review period is the basis for patent extension. Basically, a regulatory review period is composed of two parts: a testing phase, and an approval phase. The testing phase for a human drug product is the period between the effective date of an investigational product exemption (Investigational New Drug Application) and the initial submission of the marketing application (New Drug Application).

Question:How do I obtain a copy of a patent or a patent application publication?

Answer:
Copies of patents or patent application publications, shipped via the U.S. Postal Service, may be purchased for $3 each. To order a patent copy, you must provide the patent number. To order a copy of a patent application publication, you must provide the publication number.

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