Generic drugs have the same active ingredient(s) as their equivalent brand name drugs. They also have the same effects, dosage, side effects, and risks, but generic drugs are typically significantly cheaper than their brand name alternatives.
When a drug is first developed, typically only a brand name version exists. However, when that company’s patent on the drug runs out, other companies can sell the same drug under a generic name.
Generics are required to look different from the brand name drug. This means they could differ in size, shape, color and markings. They also have different inactive ingredients than the brand name drug because the therapeutic effect of a drug only comes from the active ingredient.
|Brand Name Drugs||Generic Drugs|
|Availability||Available first (before generics become available)||Only available after patent runs out|
|Cost||More expensive||80-85% cheaper|
Generic drugs are significantly cheaper than brand name drugs, because the makers of generic drugs do not have to cover the cost of developing and marketing a new product. According to the FDA, a generic drug is typically 80-85% cheaper than the brand name alternative.
For example, on Walgreens.com, the price of Allegra (180mg, 30 tablets) is $17.99 whereas the generic Fexofenadine (180mg, 30 tablets) is $11.99; Tylenol (Extra Strength, 100 tablets) is $9.49 whereas Acetaminophen (Extra Strength, 100 tablets) is $2.39.
FDA regulations mean that generic drugs are required to be as safe and as effective as brand-name drugs. Trademark laws prevent generic drugs from looking exactly the same as brand-name drugs (for example, the pill might be a different color), but the drugs’ active ingredients are identical, with the same strength, stability and purity as the brand name equivalent.
In fact, generics are required to show bioequivalence with the brand name drug they are derived from. i.e., they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. Pharmaceutical equivalence implies the same amount of the same active substance(s), in the same dosage form, for the same route of administration and meeting the same or comparable standards.
FDA standards also require that the form (e.g. tablet, patch, or liquid) and method of administration (e.g. swallowing a pill, or injection) of the generic medication be the same as the brand name.
Because they are both monitored by the FDA in the same way, there is no additional risk in taking a generic drug over a brand-name drug.
Are generics as effective as the brand name drugs?
For most drugs, generics are as effective as the brand name drug. However, there is some debate about NTI drugs. These are drugs with a narrow therapeutic index (NTI), which means there is a smaller margin of error in the dosing; minor variances in dosing can cause toxicity rather than provide a therapeutic effect. Several states have restrictions in place against generic substitutions of NTI drugs. The FDA has also tightened bioequivalence standards for NTI drugs.
NTI drugs include anti-seizure medications like carbamazepine for epilepsy, blood thinners like warfarin, thyroid medication like levothyroxine, antiarrhythmics for controlling irregular heartbeats, drugs like lithium carbonate that treat bipolar disorder, and drugs that help prevent the rejection of a transplanted organ.
Studies and meta analyses of several studies comparing the effectiveness of generics and brand name NTI drugs have not been conclusive. So at this time, caution is advised for NTI drugs. As always, talk to your doctor before switching from a brand name drug to a generic, or from one generic to another.
Risks with inactive ingredients
Generics may use different inactive ingredients and some people may be allergic to some of the inactive ingredients used by various generics manufacturers. For example, some drugs use dyes or artificial flavors that could cause an allergic reaction.
Since different pharmacies use different generics suppliers, and in fact even the same pharmacy may use different suppliers for the same generic, one can never be sure what inactive ingredients are present in a generic version of a drug. In most cases, this isn't a serious issue. After all, an allergic reaction is also possible with the inactive ingredients in a brand name drug. The difference is consistency and predictability; you can be sure that the inactive ingredients in brand name drugs aren't changing.
On March 25th 2013, the Supreme Court will hear arguments regarding the release of generic drugs. The FTC argues that brand-name drug makers are paying other drug companies to delay their release of generic versions to ensure that they can keep their drug prices high. Another case is also currently going through the Supreme Court to decide whether the makers of generic drugs are liable for any harm that a drug does, as these drugs must be identical, in content and labeling, to the brand name version.
A list of generic alternatives to brand name drugs is available here. Generic alternatives for some of the commonly used drugs include:
|Brand Name Drug||Generic equivalent||Medical use|
|Adderall||Dextroamphetamine and Levoamphetamine||ADHD treatment|
|Advil||Ibuprofen||Painkiller, fever reducer|
|Advair Diskus, Seretide||Fluticasone + Salmeterol||Asthma|
|Agiolax||Sphagula husk + Senna||Gastrointestinal disorders|
|Amoxil||amoxicillin||Antibiotic used to treat infection|
|Cymbalta||Duloxetine||Depression, Anxiety disorders|
|Lantus||Insulin analog (Insulin glargine)||Type 2 and type 1 diabetes|
|Motrin||Ibuprofen||Painkiller, fever reducer|
|Nurofen||Ibuprofen||Painkiller, fever reducer|
|Prevacid||Lansoprazole||Acid reflux, GERD|
|Provigil||Modafinil||Narcolepsy, obstructive sleep apnea|
|Remicade||Infliximab||Crohn's disease, Rheumatoid arthritis|
|Ritalin||methylphenidate||ADHD, postural orthostatic tachycardia syndrome and narcolepsy|
|Rituxan, MabThera||Rituximab||Non-Hodgkin’s lymphoma, Rheumatoid arthritis|
|Spiriva||Tiotropium||Chronic obstructive pulmonary disease|
|Truvada||Tenofovir + Emtricitabine||HIV infection|
|Tylenol||Acetaminophen||Pain reliever, Fever reducer|
|Vicodin||Acetaminophen + hydrocodone||Moderate to severe pain relief|
|Xanax||Alprazolam||Anxiety, Panic disroders|
- FDA.gov on Generic drugs
- Generic Drugs - Questions and Answers
- Drugs.com Top 100 Drugs by Sales
- Generic Drugs, Are They as Good as Brand Names? - MedicineNet.Com
- Bayer Joins Merck in Fighting Generic Drugs Case - Bloomberg
- Supreme Court to hear generic drug suit next week - Politico
- Generic and Brand Name Drugs: Understanding the Basics (PDF) - Depression and Bipolar Support Alliance
- What are generic drugs and are they safe? - Consumer Reports