In 2000, a federal appeals court overturned a lower court's ruling which had allowed an extension of Eli Lilly and Co.'s patent for Prozac, a selective serotonin reuptake inhibitor used to treat depression and a number of anxiety disorders. The extension would have allowed patent protection through the year 2003. With the ruling, generic versions of Prozac became available to the consumer in 2001. Other popular medications, including Bristol-Myers Squibb Co.'s anti-anxiety medication BuSpar, will also be losing patent protection in the next few years.
What does this mean to you, the consumer? If you use any of these medications, expect to save money when generic versions become available. If you're paying for your medications directly, you will see savings right away. If your insurance covers medication, savings should be passed on to you in the long run. Either way, you may be confused about generics and why they can save you money. Below you will find answers to your frequently asked questions about generic medications.
Q. What is a generic drug?
A. A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Q. Do generic drugs really save money for the consumer?
A. Despite being chemically identical to brand name drugs, generic drugs are usually priced much lower. An example may be seen with the anti-anxiety medication Klonopin and its generic version clonazepam. A typical price for 90 0.5 mg tablets of Klonopin is about $85 US. 90 0.5 mg tablets of clonazepam are about $20.
Q. Do generic drugs work as well as brand name drugs?
A. To gain approval from the US Food and Drug Administration (FDA), generic drugs must meet the same standards as brand name drugs. A generic must:
- contain the same active ingredients as the brand name drug (inactive ingredients may vary)
- be identical in strength, dosage form, and route of administration
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same standards of FDA's good manufacturing practice regulations required for brand name drugs
Q. Why aren't there generic versions of all medications?
A. New drugs are developed under patent protection. The company which creates the drug has the sole right to sell the drug until the patent expires. The patent is meant to protect the company's investment in the drug's development. When the patent expires, other companies may apply to the FDA to sell generic versions.
Q. Which drugs used for anxiety disorders have generic versions?
A. The older the drug, the more likely it has a generic version. Most tricylic antidepressants may be purchased in generic form along with the benzodiazepines. Newer medications such as the selective serotonin reuptake inhibitors are still under patent protection (however, this will be changing soon for some, as mentioned above). It's always a good idea to ask if there is a generic version of your medication and if your doctor and pharmacist think the generic is right for you.
Q. Where can I read more about generic drugs?
A. The FDA's Office of Generic Drugs provides a great deal of information, including Generic Drugs: Questions and Answers
