Brand-name drugs (the reference drug or first time the drug is approved by the Health Authority) are prescription pharmaceuticals that are protected by patents or other forms of exclusivity. These drugs, must first gain approval from a country’s regulatory authority. Applications for approval typically includes documentation that establishes a drug’s clinical safety and efficacy. Once the drug receives approval, the innovator company can then exclusively market and sell the “brand-name” product, for as long as they have patent protection or market exclusivity.
Developing new medicines can take years and significant investment. Only a few promising therapies ever enter clinical trials. Fewer still are approved for sale by health authorities, at which point marketing to healthcare providers and consumers begins.
Because patents and exclusivities can last many years, they serve as an incentive to developers. During the periods protected, developers generally recoup their investments and earn a profit.
Mylan offers multiple brand-name drugs in various countries.
To learn more about our product portfolio in the United States, click here. To learn more about our portfolio in other countries, please visit our country pages.
Branded generics are generic drugs that have been given a different brand name than the reference product.
Mylan markets branded generic prescription drugs in many countries after approval by the appropriate health authorities . These products are more sensitive to promotion than unbranded generic products. They therefore represent a focus of our sales representatives and product-level marketing activity.