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Are generic drugs patented?
No, but having a patent does not make it any more reliable.
Manufacturers patent their products so that they could have the exclusive rights to produce a drug for a period of time. As defined, a patent is a policy provided to people who seek protection for their intellectual property. In effect, the government gives the inventor the right to produce and sell his invention exclusively in exchange for sharing the details of the invention to the public domain. As an intellectual property, owners can also license their patented products as well as mortgage, assign, or transfer the right to other parties. These rights only apply until the patent expires.
Generic versions of these medicines can be produced after their patent expires since it will not be legal for anyone to take advantage of the invention without repercussions. The length of applied patents for US drug products is 20 years. Although it may seem that it is a long time, we have to remember that patents must be approved first before clinical trials begin. Excluding clinical trial and testing, the life of a US drug patent is pegged at seven to twelve years.
Generic pills can be produced based on these 4 reasons:
- The patent has expired
- The patent for the drug is invalid, or hard to enforce
- Non-existence of a drug patent from the start
- Under government where U.S. patents are not enforced.
For guidance on the legal issues of generic medicine, you can refer to the Drug Price Competition and Patent Term Restoration Act of 1984. This law essentially increased the protection of patented products, but also allows generic medicines makers to produce their medicines. Generic drugs are effective, safe and FDA approved.
The process of patenting is not only exclusive in the United States. There are different standards of patenting in India in China and other countries. The bottom-line is that with the different patenting policies from different countries, patenting is a non-issue in the long run.
India passed the Patent Act in 1970, which allows Indian companies to make generic and cheaper alternatives for well known medicines. Then on 2004, India changed its patent standards to allow patents on chemicals. As of date, there are approximately 6,000 patents filed under the Indian government. India’s patent system is designed to encourage firms to invest in low-cost manufacturing processes and make the generic medicines widely available to the market at low prices.
With this development, India is now producing roughly half of the world’s antiretrovirals, most with modest cost and with the country also supplying much of the ingredients for the drug.
All our medications are produced by the following Indian Pharmaceutical Companies:
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