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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Tivicay (dolutegravir) is an integrase strand transfer inhibitor (INSTI) that is indicated for use in combination with other antiretroviral (ARV) medicines for the treatment of HIV infection. Tivicay is a 50mg tablet, which may be taken with or without food. In treatment-naïve patients, and in treatment-experienced patients who have not taken an integrase inhibitor, Tivicay is taken in most cases once a day and is booster free. Tivicay has been extensively studied in five phase III clinical trials involving over 3,000 adult people living with HIV. Tivicay was approved by the U.S. Food and Drug Administration (FDA) in August 2013; by the European Commission in January 2014; by the Canadian regulatory authority Health Canada in October 2013 and by the Japanese Pharmaceuticals and Medical Devices Agency in April 2014. In 2016, the FDA approved a reduction in the weight limit from at least 40kg to at least 30kg for the treatment of HIV with Tivicay, meaning children and adolescents aged 6 – 12 years old will now be eligible to receive this treatment option.
