USFDA Generic Drugs: Questions & Answers

Generic Competition and Drug Prices
Generic competition is associated with lower drug prices, with the entry of the second generic competitor being associated with the largest price reduction.

What standards must generic medicines meet to receive FDA approval?

Drug companies can submit an abbreviated new drug application (ANDA) for approval to market a generic drug that is the same as (or bioequivalent to) the brand-name version. FDA’s Office of Generic Drugs reviews the application to make certain drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.

An ANDA must show the generic medicine is equivalent to the brand in the following ways:

• The active ingredient is the same as that of the brand-name drug/innovator drug.
  • An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating.
  • Generic drug companies must provide evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence.
• The generic medicine is the same strength.
• The medicine is the same type of product (such as a tablet or an injectable).
• The medicine has the same route of administration (such as oral or topical).
• It has the same use indications.
• The inactive ingredients of the medicine are acceptable.
  • Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name version.
  • Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence.
• It lasts for at least the same amount of time.
  • Most medicines break down, or deteriorate, over time.
  • Generic drug companies must do months-long “stability tests” to show that their versions last for at least the same amount of time as the brand-name.
• It is manufactured under the same strict standards as the brand-name medicine.
  • It meets the same batch requirements for identity, strength, purity, and quality.
  • The manufacturer is capable of making the medicine correctly and consistently.
    • Generic drug manufacturers must explain how they intend to manufacture the medicine and must provide evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures, and FDA inspectors go to the generic drug manufacturer’s facility to verify that the manufacturer is capable of making the medicine consistently and to check that the information the manufacturer has submitted to FDA is accurate.
    • Often, different companies are involved (such as one company manufacturing the active ingredient and another company manufacturing the finished medicine). Generic drug manufacturers must produce batches of the medicines they want to market and provide information about the manufacturing of those batches for FDA to review.
• The container in which the medicine will be shipped and sold is appropriate.
• The label is the same as the brand-name medicine’s label.
  • The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is protected by patents or exclusivities. A generic medicine can omit the protected use from its labeling and only be approved for a use that is not protected by patents or exclusivities, so long as that removal does not take away information needed for safe use. Labels for generic medicines can also contain certain changes when the drug is manufactured by a different company, such as a different lot number or company name.
• Relevant patents or exclusivities are addressed.
  • As an incentive to develop new medicines, drug companies are awarded patents and exclusivities that may delay FDA approval of applications for generic medicines. FDA must comply with the delays in approval that the patents and exclusivities impose.

The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public.

Is a generic version of my brand-name medicine available?

In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a generic version of your brand-name medicine available:

• Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling.
• Search for generic equivalents by using the online version of the “Orange Book.”
  • First, search by proprietary or “brand” name.
  • Second, search again by the active ingredient name.
  • If other manufacturers are listed besides the brand-name manufacturer in result for searches by the “active ingredient,” they are the generic product manufacturers.
• For very recent approvals, consult the First Generics List.

If you are unable to locate a generic version of your brand-name medicine, it may be that the brand-name medicine is still within the period of time when it has exclusive rights to the marketplace, to allow drug companies to recoup their costs for the initial research and marketing of the brand-name or innovator drug. It is only after both patent and other periods of exclusivity are resolved that FDA can approve generic versions of the medicine.

Does FDA monitor side effects or safety issues with generic medicines?

Yes. After FDA approves any medicine, including generics, it continues to examine the medicine’s safety. FDA takes several actions to ensure safety and quality before and after a new or generic medicine is marketed.

FDA staff continually monitors drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and high quality.

FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product (brand-name and generic counterparts) is used or manufactured.

Due to limited resources, FDA is unable to perform independent clinical studies, and the agency lacks the regulatory authority to require the generic industry to conduct such studies. FDA will, however, continue to investigate these reports to ensure that it has all the facts about these possible treatment failures and will make recommendations to health care professionals and the public if the need arises. Currently, to better understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products, FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur.

Please visit our Drug Quality Sampling and Testing page to learn more about FDA’s efforts to help ensure the regulatory standards for brand-name and generic medicines continue to be met throughout a product’s lifecycle.