Drug Patents and Generic Pharmaceutical Drugs

Dec 2022

When a drug is manufactured and released to the market in the initial period, it is sold under a certain brand names and can only be availed from a pharmacy after being prescribed by the doctor. The patent of the drug is owned by a few brands who are the only eligible brands to manufacture medicine using the same composition, market the product commercially and make profit from it.

Across US, a drug patent has a validity of over 20 years even though the tenure varies between countries as well as on the drug.

And since the companies appeal for the patent long before the drug even undergoes its safety and efficacy trial. And by the time it is released in the market, the leasers get around 10-11 years.

After the tenure is over, the patent is passed on to some other drug manufacturing companies who also leases the right to market the product. But the time the second manufacturer earn the patent, the drug is already categorized as generic drug. And as per the rule of US FDA, generic needs to have identical drug composition in terms of safety, efficacy, route, usage, pharmacokinetics, drug administration, and usage of drug administration.

So, a drug can also be categorized as a generic drug when the composition of the drug matches the above said features. And a pharmaceutical company can only manufacture the drug when:

The patent of the drug has expired
The company who owns the patent now certifies that the patent of the drug are invalid, or unenforceable.
No patents were issued for drug anytime
It is being manufactured in a country where patent is not required

Once the drug is commercialized and categorized as a generic drug. The patent holder’s monopoly is dropped. And this at the same time boost competition which eventually leads to a drop in the drug’s price which eventually means that more drug can reach out to more people now.

But, the company who owns the present patent of the drug may choose to extend the tenure of the patent by manufacturing a potent version of this drug that has more significant benefits.

But, the second version needs to go under clinical trial as well along with reapplication for the patent.

Moreover, the upgrade version may need to compete with the original module in order to stay in the market by removing the older one.

Trending Blogs

Lack of Music Publishing Knowledge Robbing Indian Artists of their Rights

In India there has been a lack of knowledge regarding publishing music. It can be said that a large part of publishing an art for is still unexplored. It is not about the common people but the artists and the music companies are oblivious towards it. At the initial stage due to lack of knowledge […]

Evaluation Intellectual Property Rights

Intellectual property has always existed since the dawn of time but there were no laws in place for their protection. Intellectual property is intangible asset, be it music, creative writing, arts, discoveries, inventions and development of unique words, symbols and artwork. Intellectual property rights is a generic term that covers copyright, industrial design, trade secrets, […]

The Common Law Protection Of Trade Secrets And The Need For A Statue

Introduction: A trade secret is anything you use in your business that gives you an advantage over your competitors. A trade secret can be a recipe, process, formula, strategy, technique or device that your competitors do not know, do not have, and cannot use. With development in technology, as well as the ease of sharing, […]

Breaking News: Toyota Loses Trademark Battle over Prius at Indian Supreme Court

The plaintiff, in this case, is Toyota Jidosha Kabushiki Kaisha and they seek to prevent the defendant, a spare parts supplier by the name M/S Prius Auto Industries Limited, from the usage of the trademarks- “Toyota”, “Innova”, and “Prius”. According to the finding of the court, two of the three trademarks mentioned, namely Toyota and […]

3D Printing and IPR

The three-dimensional or 3D printing service is different from the traditional way of manufacturing. In the 3D process, objects are created layer wise to get the desired three dimensional impacts. Since the inception of this latest idea in 1980s, it has gone through several changes in the technology used. This requires use of different production […]

Alibaba IPR Report Shows Ideal Brand Protection Program

As per sources, e-commerce giant, Alibaba group has successfully gained success using intellectual property rights-protection. The giant has been able to offer quality service due to well integration of the latest technological improvements coupled with partnerships with top-rated brands. Also, external stakeholders assisted the giant in offering quality service to proactively monitor, go through rights-holders […]

Celebrity Rights – Public, Private or Intellectual Property

Celebrity lives are mostly public these days through different sources but they too want to maintain certain privacy. This has triggered the need to maintain celebrity rights on different properties. There are several company options that are selling products with celebrity faces from bags to soaps to cosmetics to many others. It requires suitable celebrity […]

Intellectual Property and its Role in the Pharmaceutical Industry

Intellectual property rights are considered to be an important asset of any corporate unit. It is an indication of the creation of mind and the work that makes one entity different from the other. With better IP or intellectual rights, it would be easy to promote the possible innovations and this would be useful in […]

For a music composer, lyricist, a producer, or any performer, protecting music is a big concern under the U.S. copyright protection laws. By copyright, it indicates legal protection that is offered to the original work of music of the creator from others to use it by their name. The copyright law shall prevent others from […]

Drug Patents and Generic Pharmaceutical Drugs