Men
Erectile Dysfunction
In answering the question, it may be useful to know first what Cialis is and why the issue of patent expiration is important.
Cialis is one of the brand names for Tadalafil, a drug used to treat erectile dysfunction or persistent difficulty to achieve and maintain an erection of the penis sufficient to have sex. It is similar to other erectile dysfunction drugs, Viagra and Levitra. Tadalafil is also used for treating pulmonary arterial hypertension under the brand name, Adcirca.
Cialis was discovered in August 1991 by the biotechnology company, Icos Corporation and approved by the U.S. Food and Drug Administration (FDA) in November 2003. It was later purchased by the pharmaceutical company, Eli Lilly and Company, when the patent of the drug was transferred to the company.
A patent is a form of intellectual property (non-physical property that is the result of creativity), which gives its owner the legal right to exclude others from making, using, selling, and importing an invention for a limited period of years, in exchange for publishing and enabling public disclosure of the invention at the end of the period of protection.
Although drug patents last 20 years after the invention of the drug, it can take up to 8 years for a pharmaceutical company to do enough testing for approval from the FDA and investors.
While other patents have a limited length from the approval date, drug patents follow a different set of rules, which give patent extensions to name-brand drug companies to compensate for delays in the FDA approval process. This allows for a patent extension for up to five years, regardless of the length of time it took for the FDA to approve the drug. It also further caps the protected amount of time to 14 years, depending on the approval delay time frame. This ensures the patent holder can assume profitability before generic drug companies move into the picture and are permitted to manufacture their versions of the identical makeup of the original drug, to encourage price reduction due to competition.
The patent protection for Cialis was set to expire on April 26, 2020. However, in July 2017, Eli Lilly and Company entered into a settlement agreement with multiple generic companies to resolve pending patent litigation in the court regarding Cialis. As part of the agreement, Eli Lilly’s patent protection of Cialis is expected to have ended at the earliest, on September 27, 2018.
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