What is the difference between patents and exclusivity?

Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.

What does loss of exclusivity mean?

Loss of exclusivity (LOE) is a natural milestone in a drug’s lifecycle. Focused and effective late lifecycle management can preserve meaningful value for the brand. Kellogg’s Corn Flakes had “generic” competition within a month of its launch more than 100 years ago, and yet it’s still the dominant brand in its market.

What happens when a drug loses exclusivity?

After that period of time concludes, the manufacturer must then relinquish control of the drug formula to the marketplace, a transition called loss of exclusivity (LOE). After LOE, multiple manufacturers can sell generic versions of the original drug.

What does it mean when a drug patent expires?

When a drug’s U.S. patent expires, manufacturers other than the initial developer may take advantage of an abbreviated approval process to introduce lower-priced generic versions. In most uses, generics are clinically equivalent to the original branded drug. Average drug prices dropped after expiration.

Can patents be extended?

Without a change in the law, a patent cannot be extended beyond the term for which it issued. The only way to extend protection is to invent and patent an improvement to the originally patented invention.

How long is patent exclusivity?

Once a new drug is approved, the FDA provides a guaranteed period during which a generic version cannot be approved, regardless of the time remaining on the new drug’s patent. This regulatory exclusivity typically runs for at least six years for new drugs.

What does drug exclusivity mean?

Exclusivity is a period of time when a brand-name drug is protected from generic drug competition. Exclusivity is designed to promote a balance between new drug innovation and generic drug competition. In most cases, a brand-name drug with a new active moiety has a five-year exclusivity.

How long does exclusivity last for a patent challenge?

Patents only offer exclusive rights to the holder for a term of 20 years from filing. The time spent testing and developing drugs easily cuts into this term depending on when the patent is granted.

What is drug exclusivity?