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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?

Assorted Medication

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?

Judges gavel and medication

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 process.

There is also a further extension available for drugs that were manufactured for children. This extension is known as the pediatric exclusivity extension and can grant an additional six months to the patent, but it can only be applied twice.

3. Why would exclusivity expire before a patent?

Patents and exclusivity both apply to new drugs in different ways. A drug patent can be issued or expire at any time, regardless of the drug's current approval status.

Exclusivity is attached to a drug once it has been approved and it has met all the statutory requirements. While some drugs have both patent and exclusivity protection, others may have one or the other, or neither of them.

Patents and exclusivity may not run concurrently, and they may not even cover the same aspects of the drug. You can find out more about a drug's current patent and exclusivity status by checking the Orange Book, which you can learn more about here.

Why Do Drug Patents Expire, and Why Is This So Important?

Various pills coming out of a rolled up hundred dollar bill

Imagine for a minute that once a drug company comes up with a new drug, it's tested and approved and proves to be extremely effective at treating the desired condition. Next, that drug is put onto the market for whatever price they choose, and that company has the exclusive lifetime rights to sell that drug.

Patients would be forced to pay that higher price or not use that drug at all.

Limiting the length of drug patents gives pharmaceutical companies the opportunity and time to recover their investment costs and even make a profit, but eventually, a generic version of the drug will be released at a fraction of the cost, giving people more access to the drug.

There's a fine balance between generic drugs and brand-name drugs. After all, if drug companies weren't financially incentivized to research, create, test, and produce new drugs, then who would be?

While in a perfect world, we'd love to see all drugs available for free to all people, there's only so much time and effort that can be put into different medical conditions at one time.

The current system may not be perfect, but it's doing the best it can.

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Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions that optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process with the individual and the pharmaceutical partner in mind.

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