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Replies to post #424063 on Amarin Corp Plc (AMRN)
05/08/24 5:05 PM
Studies a U.S. FDA-regulated Drug Product: No
Based on the search results, the key differences between patents and regulatory exclusivity for drugs are:
Patents are granted by the U.S. Patent and Trademark Office and protect the intellectual property of the drug inventor, typically lasting 20 years from the filing date. Exclusivity is granted by the FDA upon drug approval and prevents competitors from submitting generic or similar versions for a specified period of time.
Patents can be obtained at any stage of drug development, while exclusivity only comes into play after the drug is approved by the FDA.
Exclusivity periods are typically shorter than patent terms, ranging from 3-12 years depending on the type of exclusivity (e.g. new chemical entity, orphan drug, pediatric).
Patents can be challenged and invalidated, while exclusivity is more secure and guaranteed as long as the statutory requirements are met.
Patents and exclusivity can run concurrently, but exclusivity often expires before the patent term ends. The expiration of the later of the two is what determines when generic competition can enter the market.
In summary, patents and exclusivity serve complementary but distinct purposes in protecting drug products, with exclusivity providing an additional layer of protection beyond just the patent term. The interplay between the two is complex but critical for understanding the timing of generic drug entry.
