By some estimates, more than 80 percent of prescriptions in America are filled with generic medications. You’re probably familiar with them yourself. Health insurance plans tend to favor generic formulations because they have the same therapeutic effects as brand-name drugs yet cost far less. But generic drugs are also popular in veterinary medicine, even without an insurance company middleman. In fact, when your veterinarian prescribes medications for your horse, you may have the option of choosing between a generic or name-brand product. Here are five facts about generic medications to consider when making that decision.

1. There is no functional difference between generic and name-brand drugs.

Generic drugs are equivalent to brand-name drugs in dosage, strength, route of administration, performance characteristics and intended use. Once the patent of a brand-name drug expires, manufacturers are free to create a bioequivalent drug. Generic drugs contain the same active ingredients as the brand-name product but may incorporate different inactive components, such as preservatives or flavorings. The label designs, color schemes and other aspects of pioneer products are protected by trademarks. But the generic drugs themselves can look similar or identical to the original. Likewise, the name and look of the generic product’s labeling might differ from that of the brand name product. But the indications, safety warnings and instructions for use will be the same.

2. Generic products must receive approval from the Food and Drug Administration (FDA).

All medications—whether for veterinary or human use—undergo a federal review process before being allowed on the market. For a new drug, manufacturers file a New Animal Drug Application (NADA). New drugs are protected by patents, sometimes up to 20 years. After a patent has expired, a generic drug manufacturer can file an Abbreviated New Animal Drug Application (ANADA). While reviewing ANADAs, the FDA relies on the safety and efficacy studies conducted for the approval of the original drug rather than requiring that those tests be replicated. However, the application for the generic drug must establish that the product meets other standards, such as:

• bioequivalence, meaning the generic must deliver the same amount of active ingredient into a patient’s bloodstream in the same time frame as the original

• manufacturing standards adhering to the same practices as brand-name manufacturers to ensure product quality and consistency. The FDA routinely conducts inspections of facilities where generic drugs are manufactured to ensure they comply with the Current Good Manufacturing Practice. The CGMP assures the quality, safety and efficacy of pharmaceuticals.

• labeling requirements that closely match the brand name labeling to avoid confusion and ensure  proper dosing.

In summary, using a generic version of a pioneer product can be done with complete confidence due to the rigid requirements for ANADA approvals.

3. Generic drugs are less expensive because they have fewer development and marketing costs.

The primary purpose of generic drugs is to provide the same therapeutic benefits as brand-name drugs at a lower cost. Manufacturers can bring generic drugs to market without incurring the research, development and marketing costs associated with introducing a new patented formula. Each year around 20 times more generic drugs are approved than new drugs. Typically, the FDA approves a generic drug only after any relevant patents or exclusive marketing rights for the approved brand-name version have expired.

4. Like their brand-name counterparts, generic drugs are subject to FDA monitoring of adverse reactions.

When it comes to adverse event reporting and investigation, generic drugs are subject to the same requirements as are brand-name formulas. To report a possible adverse reaction, owners or veterinarians can contact the manufacturer, which in turn is required to submit a report to federal officials or to contact the FDA directly.

5. It pays to educate yourself about the different types of equine medications.

In addition to generic and brand name drugs, there are also compounded medications. We will discuss these in our next installment. To learn more about each of these, talk with your veterinarian, contact drug companies directly or visit the FDA website.