Generic Drugs and Their Patents

When a generic drug is produced? A drug company starts marketing a generic drug, once the patent on the branded drug expires. Furthermore, as long as the patent on the branded drug is in effect, no generic will be allowed to be produced and marketed.

Generic drugs are commonly produced in the following instances:

  • The drug's patent has already lapsed or expired
  • The generic drug company certifies the invalidity and unenforceability of the branded drug company; in short, can never be infringed
  • For drugs or medicines which are never patented
  • Produced in countries where patents are not enforced

When the brand drug's patent expires, this stops or invalidates the license of the company to sell it. The life span of a drug patent usually differs from one country to another. Basically, there is no way for the company to renew the expired patent. Instead or renewing, the company creates a new version with some relevant changes. However, this usually requires clinical tests.

The cost of developing generic versions of the brand with expired patent is much smaller because the producers will no longer have to deal with the different expenses for different trials and tests, marketing, sampling, etc. The original version is already approved and tested so there is no need for the producers to spend on such expensive procedures.

Patent is usually issued to the producer from the time it has start developing a particular drug. In this way, the producer should make all possible ways to market and sell its patented medicines before the expiration comes.

The exclusivity of a generic drug comes with a 180-day period in some cases and this was promulgated by the US Food and Drugs Administration. At this point in time, only one or few are given the authority to produce generic versions of branded drugs which already have had their patents expired.

Because patents come with an expiry and obtaining them can be somewhat expensive, drug companies often spend millions and millions of dollars just to give the protection these patents deserve.

And when you see generic drugs sold with license from patent holders, these drugs are actually known as authorized generic medicines and they are not in any way affected by the 180-day exclusivity period. This is due to the fact that these generic drugs are categorized under the original medicine application of the patent holder.

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