Drug Patents and Drug Exclusivity

 

How long do drug patents last, and can you get them extended? Let's check it out!

If you've ever wondered why some drugs are more expensive than others and why you can only get certain drugs from specific pharmaceutical companies, then you're not alone.

Why are there more affordable generic versions of some drugs available but not all drugs?

Thanks to the FDA and its comprehensive guide on pharmaceutical patents, these are just some of the questions we will answer below in our drug patent FAQs.

Drug Patent FAQs Answered

1. What's the difference between patents and exclusivity?

A drug patent can be issued or expire at any time, regardless of the drug's current approval status. Exclusivity attaches to the drug upon approval of the drug or product as long as the statutory requirements have been met.

While some new drugs may have both patent and exclusivity protection, others may have one or the other or none at all. Exclusivity was created and designed as a way to promote a balance between new drug innovation and greater public access, which results from generic drug competition.

Developing new drugs can be not only time-consuming but also expensive. If generic versions of drugs were immediately allowed to hit the market, then drug companies wouldn't be able to recoup the financial costs associated with new drugs.

By granting limited patent and exclusivity periods, it creates a balance between promoting new drug development and giving patients better and more affordable access to generic drugs in the long term.

2. How long is the average term of a drug patent?

Drug patents are set in place by statute. The current term for a new drug patent is twenty years from the date the application was filed in the United States. There are a variety of other factors which may also affect the length of the patent.

There are extensions that pharmaceutical companies can apply for, which will enable them to recoup some of the lost time spent in the FDA approval process. This extension period covers up to five years, depending on the length of the approval proces