Now, these patent protections and exclusivity periods will vary from country to country. Once these periods expire, prevailing market conditions will usually kick in and determine whether or not a generic variant is manufactured.
There are still a lot of branded drugs whose patents have yet to expire, and big pharma continues to develop and patent new drugs. In recent years, another group of significant factors that affect generic drug performance have come to light — physical characteristics of drug products.
We are now considering physical characteristics alongside pharmaceutical equivalence and bioequivalence when we review certain new generic drug applications. Research has shown that changes in the physical characteristics of drugs can impact patient compliance with treatment regiments and also cause medication errors.
When the appearance, particularly the color and shape, of a generic drug is different from the RLD, it becomes increasingly difficult for patients and health care professionals to correctly identify medications. The risk of error is especially high with elderly patients who take multiple medications each day and are used to sorting their medications by shape, color, and size.
It became clear to us that differences in the appearance of a generic drug from the brand name drug or other generic products for the same indication can negatively affect acceptance and use of generic drugs by both patients and health care professionals.
This year, FDA issued a final guidance for industry to explain our current thinking on size, shape, and other physical attributes of generic tablets and capsules. The recommendations in the guidance are meant to assist generic drug manufacturers in drug development and assure manufacturers that they are on the right track with their application. The guidance is conservative; it does not restrict industry, but does provide some parameters from both a manufacturing and clinical safety standpoint.
Within the guidance, FDA also gives industry the opportunity to vary from our recommendations. Brand names often suggest a characteristic of the drug. For example, Lopressor lowers blood pressure, Glucotrol controls high blood sugar glucose levels, and Skelaxin relaxes skeletal muscles.
The term generic, when applied to such items as foods and household products, is used to describe a less expensive, sometimes less effective or lower-quality copycat version of a brand-name product. It is not enough for them In fact, generic drug makers manufacture many brand-name products for companies that control the brand names. Sometimes, more than one generic version of a drug is available. For example, many manufacturers sell versions of acetaminophen , a nonprescription drug commonly used to relieve pain and fever.
In the United States, a company that develops a new drug can be granted a patent for the drug itself, for the way the drug is made, for the way the drug is to be used, and even for the method of delivering and releasing the drug into the bloodstream. Thus, a company often owns more than one patent for a drug. Patents grant the company exclusive rights to a drug for 20 years. Additional patents can sometimes be filed to extend the patent life. Usually, about 10 years elapse between the time a drug is discovered when the patent is obtained and the time the drug is approved for human use, leaving the company only about half of the patent time to exclusively market a new drug.
The Food and Drug Administration FDA may choose to accelerate the approval process for drugs to treat acquired immunodeficiency syndrome AIDS , cancer, and other life-threatening disorders when no current effective treatment exists. After a patent has expired, other companies may produce and sell a generic version of the drug that is approved by the FDA. They typically sell their product at a lower price than the original brand-name drug because the generic manufacturer does not have to recover the original costs of drug development and usually spends much less on marketing.
It is important to note that there will always be a slight, but not medically significant, level of expected variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines.
When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable. For example, a very large research study 1 comparing generics with brand-name medicines, found that there were very small differences approximately 3. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and clinically acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine.
Research study: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease A study of 38 published clinical trials showed no evidence that brand-name heart medicines worked any better than generic heart medicines. Trademark laws in the United States do not allow a generic drug to look exactly like other drugs already on the market.
Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different. Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively.
This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug. Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical human studies that were required of the brand-name medicines to demonstrate safety and effectiveness.
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