In the end, Apotex is working for everyone. At some time in their lives, most people will need prescription medication of one kind or another, whether to manage pain, manage high blood pressure or treat another condition or illness. In our facilities and offices around the world, Apotex is working to produce quality affordable medications for patients in every corner of the globe.
Frequently Asked Questions
Q. What are generic drugs?
A. A generic drug is a therapeutic equivalent to a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
Q. Who inspects and governs generic drugs?
A. The FDA (Food and Drug Administration) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The FDA periodically inspects manufacturing facilities, clinical trials, pharmacies, etc. to uphold consistent quality assurance.
Q. Are generic drugs as safe as brand-name drugs?
A. Yes. The FDA requires that all drugs are proven safe and effective through clinical trials and post-market analysis. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
Q. Are generic drugs as strong as brand-name drugs?
A. Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
Q. Are brand-name drugs made in more modern facilities than generic drugs?
A. No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
Q. Why are generic drugs less expensive?
A. Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. The generic manufacturers have lower development costs and can afford to sell their product at a lower price. Once generic drugs are approved, there is greater competition, which also keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.
Q. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
A. In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other “inactive” ingredients may be different.
Q. Do generic drugs take longer to work in the body?
A. No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
Q. Does every brand-name drug have a generic counterpart?
A. No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
Q. What characterizes a successful generic drug company today?
A. The mission of a successful drug company is to provide quality, affordable pharmaceuticals while maintaining a competitive edge, constantly embracing change in order to fulfill the needs of our valued customers, shareholders and dedicated employees. This continued focus is parallel with an effort in lowering health care costs for the patients that are prescribed pharmaceutical products by developing and introducing new generic pharmaceuticals into the national market.
Q. How do consumers request generic drugs?
A. Consumers seeking generic drugs can simply ask their doctor or pharmacist.
Q. What is an ANDA?
A. An "ANDA" is an Abbreviated New Drug Application. It is the process of obtaining approval to market a generic drug. An ANDA contains information demonstrating that the generic drug is bioequivalent to the brand-name product and certification that the generic drug does not infringe on any patent for the brand-name product listed in the Orange Book or certification that the listed patents are invalid.
Q. What is Bioequivalence?
A. It is the Food & Drug Administration requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximately the same amount over approximately the same period as the active ingredient of the innovator drug. Bio-equivalence is demonstrated in two ways. Dissolution testing determines if the generic drug product dissolves in approximately the same amount of time as the innovator product. Blood-level testing is done by giving the generic drug product to humans and measuring how much of the drug enters the bloodstream, how fast it does so, and how long it takes to leave the body.