About Generics

Q. What are generic drugs?
A. Generic drugs offer similar benefits as Branded drugs in terms of dosage, safety, and strength. They are taken in the same way as branded drugs, providing the same results. The only difference is, generic drugs are quite cheaper than branded drugs.

Q. Who inspects and governs generic drugs?
A. The federal agency of the United States ‘Food and Drug Administration’ or FDA is established by the government to protect the public health by ensuring the safety, efficacy, and security of human. The federal body is also responsible for assuring the security, safety, and efficiency of all veterinary drugs, medical devices, cosmetics, radiation-emitting products, nation’s food supply, and biological products.
The FDA assists the safety of public health by accelerating innovations responsible for making medicines and foods safer, effective and cheaper to purchase. FDA also employs a process to introduce public with science-based information, which results in improved medicinal and food usage for an improved life. FDA ensures the quality compliance of manufacturing facilities, pharmacies, clinical trials, etc.

Q. Are generic drugs as safe as brand-name drugs?
A. Yes. The FDA only allows drugs which exhibit similar safety and efficacy as Brand-name counterparts. As generic drugs comprise the same active ingredients and possess the same beneficial characteristics as branded drugs, they are completely safe to use.

Q. Are generic drugs as strong as brand-name drugs?
A. Yes. FDA wants generic drugs to possess 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. Not at all. Both Generic Drugs and Brand-name Drugs follows the same standards complying to good manufacturing practices. In a yearly average, FDA conducts more than 3500 inspections to ensure the manufacturing standards of companies. So, the FDA would never allow pharmacies to manufacture drugs made under inferior quality facilities. All generic firms have the same standard facilities similar to brand-name pharmaceutical companies. Surprisingly, an estimated 50 percent of the generic drug is manufactured by Brand-name firms. These companies make copies of their own drugs but sell them without mentioning the brand name.

Q. Why are generic drugs less expensive?
A. Generic Drugs are manufactured after the lapse of patent protection of the Brand-name drug. A generic drug manufacturer doesn’t have to bear the investment costs as the developer of a new drug. The investment of a new drug is protected by the patent which includes protection of research, development, marketing, and promotion. Upon expiration of the patent, manufacturers can apply to the FDA to sell generic versions of the drug. Once the approval comes to place, almost all companies start producing the drug, which is also a major reason why the price remains down out of the competition. Today almost half of the drugs are available in a generic counterpart.

Q. If brand-name drugs and generic drugs have the same active components; why do they look different?
A. There are two types of ingredients in a drug; active and inactive. While the law allows the use of active ingredients in a generic drug, it doesn’t allow a generic drug to resemble the similar look of a brand-name drug. Therefore, inactive ingredients like colors, flavors, etc. of a generic drug are different from a brand-name drug.

Q. Do generic drugs take longer to work in the body?
A. No. As the active ingredients are same, a generic drug will work as the same phenomenon similar to brand-name drugs.

Q. Does every brand-name drug have a generic counterpart?
A. No. You won’t find a generic counterpart of a new drug as the patent protection of a new drug applies for 20 years from the date of patent’s submission. The patent protects the innovator of the drug who invests on research & development and marketing expenses. As soon as the patent expires, drug companies can develop the generic versions of the drug. The drug is only approved when it passes the test and approval of the FDA.

Q. What characterizes a successful generic drug company today?
A. A successful generic drug company offers affordable pharmaceuticals without any compromise in quality. Moreover, they stay at a competitive edge while promising to embrace change while fulfilling the requirements of shareholders, employees, and customers. The primary focus of the company must remain to lower the health care expenses of patients by introducing safe and affordable generic pharmaceuticals in the market.

Q. How do consumers request generic drugs?
A. Consumers who want generic prescription drugs then they should ask their doctor or pharmacist to prescribe them generic medicines.

Q. What is an ANDA?
A. ANDA or Abbreviated New Drug Application includes the process of obtaining approval to market a generic drug. An ANDA comes with information that states that the generic drug possesses the bioequivalence of the Brand-name Product. It also says that the generic drug doesn’t involve any patent infringement of the Brand-name product listen in the Orange Book. It also includes a certificate showing invalidation of listed patents.

Q. What is Bioequivalence?
A. Bioequivalence of a generic drug is only approved by the FDA if the generic drug’s active ingredients get absorbed and metabolized in the body as similar to the time and amount took while taking the brand-name drug. Bioequivalence is determined in two ways- dissolution testing and blood-level testing. The dissolution testing clears that the generic product took the same time to dissolve equivalent to the time as a new innovative product. The blood-level testing is conducted by giving generic drug product to humans and measuring the time taken for the drug to enter the bloodstream, the speed of the drug and the time it takes for the drug to leave the body.

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