Generic Medicaments

A generic drug is a brand-name medication whose patent has expired. In effect, all generic medications contain similar or active ingredients as those of the brand-name drugs. The best thing about generic medications is the fact that they cost about anything between 30 per cent and 50 per cent less compared to the brand-name medications, as the manufacturers of generic drugs are in stiff competition with one another, which keeps the prices of their products comparatively low.

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For instance, metformin, a drug which is used for treating diabetes, is a generic medication, which is available as a brand-name medication Glucophage. It may be noted here that while the brand names of the drugs are always used as a proper noun beginning with a capital letter, names of generic medications are written in small letters. Lopressor is a brand-name medication used for treating high blood pressure or hypertension, while one of its generic versions is metoprolol.

It is important to note that it is mandatory for all generic medications not only to contain all the active ingredients of brand-name medications, but also have them in the same quantity as the brand-name drug. However, the inactive constituents of generic medications may vary from the brand-name products. When we say inactive ingredients, we refer to the fillers as well as the coatings of the medications that help to combine the active ingredients. In addition, it is essential that the generic drugs should supply their active ingredients to the appropriate sites in the body in adequate amounts so that they generate effects similar to those of the 'innovator' or original/ brand-name medications.

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It is worth mentioning here that as many as 92 per cent of all latest discoveries of medicines are developed by pharmaceutical companies that are research-based and spend thousands of dollars every year on their research and development (R&D) activities. As these pharmaceutical companies spend lavishly in the process of developing new medications (also called 'innovator medicines'), their products are protected by means of patents for a maximum period of 17 years. The protection period of the 'innovator medicaments' actually starts from the time the manufacturers submit their applications for the patent, instead from when the company receives the approval to market it - the period between these two may often be several years. In effect, the authorities have introduced the patent protection with the aim to enable the pharmaceutical companies manufacturing innovator drugs to recover the expenses they incurred in developing an original medication before their competing firms are able to make duplicates of the products and market them at inexpensive rates.

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It may be noted here that the enactment of the Medicament Price Competition and Patent Term Restoration Act of 1984 guaranteed that all new or 'innovator' medications should enjoy a market protection for a minimum period of five years since they are approved for sale. In addition, this Act also made the approval procedure for generic medications more efficient. As per the provisions in this Act, manufacturers of generic medications were exempted from repeating all researches pertaining to the safety as well as effectiveness of the medications that were already carried out for the 'innovator' or original medicines. In its place, it is mandatory for the manufacturers of generic medications to establish that their products are comparable to the original drugs and they also work equally well.

In 1989, a scandal shook up the industry manufacturing generic medications when as many as 13 such manufacturing firms were charged with anomalies. This led to the recall of a number of generic medication and some generic drug manufacturing firms were punished with suspension orders either for infringement in their manufacturing procedures or for tendering fake information in their applications. Three employees of the United States Food and Drug Administration (FDA) pleaded guilty to receiving unlawful gratifications from the executives of the suspended manufacturing firms with the promise of hastening the process of market approval process for their generic medicines.

It is interesting to note that there are a number of pharmaceutical firms that generally market the same medication as a brand-name product and also a generic medicine. One of the leading brand-name as well as most reputed pharmaceutical firms announced in 1992 that along with its brand-name products along with economically priced versions and that it was in the process of manufacturing generic medicines for this purpose.

In addition, there are several cases where a particular pharmaceutical manufacturer develops a medication, which is distributed by many different companies under various dissimilar product names.

In effect, generic medications comprise about 33 per cent of the entire prescriptions that are recommended by physicians in the United States. In several states of the country, unless the physician has specifically prescribed 'no substitution', it is necessary for pharmacists to fill in a prescription using a brand-name medication's generic version. The only reason for doing this is that all generic medications cost much less than their brand-name products.

However, the therapeutic range of specific medications is extremely constricted because comparatively trivial alteration in the circulating levels may affect the efficiency of the drug. The results of even the slightest deviation in medications for patients suffering from congestive heart failure and epilepsy may be extremely wrecking. People who are enduring the above conditions ought to talk over to their physician prior to using any generic medication in place of a brand-name product.

In addition, generic versions of all brand-name medications are not available. The patent protection of as many as 15 original or 'innovator' medications expire every year. However, despite losing their patent protection, these medications often continue to be defended in their labelling by means of many patented indications regarding their use. Labelling for generic medications only manifests the permitted indications, which are not protected by any patent.

There are many people who actually doubt the safety and efficiency aspects of generic medications just because they cost much less compared to that of their brand-name versions. They feel concerned thinking that the manufacturers have compromised on these two aspects to make the drugs available at cheaper prices. However, the FDA has made it mandatory that generic drugs should be equally safe and effective as the brand-name medications.

In reality, generic drugs cost less than their brand-name products simply because the manufacturers have not spend any amount on research and development (R&D) that is involved in discovering a new medication as well as for marketing an 'innovator' medication. When any pharmaceutical firm introduces an 'innovator' medication into the market, it has already spent a fortune on R&D, marketing as well as for promoting the drug. The authorities grant a patent to the company for such products, thereby protecting them from competition, ensuring that the company has the sole authority to market the drug till the time the patent is in force.

As the expiry date of a drug's patent draws near, the company is allowed to submit an application to the FDA seeking authorization to manufacture the generic versions of the medication without any start up expenses for developing the medication and market it at a cheaper price. Even other companies, which have the competence to produce as well as market the generic version at economic prices, are able to apply to the FDA for approval to manufacture the generic version of the drug. When several pharmaceutical firms start manufacturing as well marketing the same medication, often there is fierce competition between them and this results in a further decline in the price of the medicament.

Therefore, the belief that the generic drugs are unsafe, of inferior quality and not as effective as their brand-name versions is totally unfounded. In fact, the FDA ensures that same standards are used by all facilities manufacturing drugs and there are several pharmaceutical firms that produce brand-name as well as generic drugs. In reality, the FDA approximates that about 50 per cent of all generic medications are manufactured by companies that produce brand-name drugs.

Another widespread misconception about generic drugs is that they take a longer time to work. However, the fact remains that as per the guidelines of the FDA all generic medications should have the same efficacy and work equally fast as their brand-name versions.

Occasionally, the color, essence or the blend of inactive constituents of generic drugs may differ from that of their brand-name versions. It needs to be mentioned here that the United States laws pertaining to trademark do not permit generic medications to have an identical appearance as their brand-name products. However, it is mandatory that the active ingredients in the generic drugs should be the same as those of their brand-name preparations to make sure that both types of medications have similar therapeutic effects.

How the medicament does its job

It is worth mentioning here that the efficacy as well as the safety of any drug largely depends on the manner in which you use the medication. At times, how you use a drug may be equally important to what drug you are actually using. Several factors, including what you are eating, when you are eating, the timing and appropriate dosage, may possibly signify the difference between staying the same, feeling better and feeling even worse.

Pharmacokinetics relates to the movements or actions of medications inside your body. In normal conditions, when you swallow any medicine, it passes through the alimentary canal to reach the small intestine where it is assimilated into the bloodstream. Subsequently, the medicine is transported to the liver, where, in several instances, it is disintegrated into a form which our body is able to use. The original medicine (or the form into which it has been disintegrated) circulated all over our system to provide the desired results and, ultimately, as is the case with the majority of medications, the kidneys excrete it quite rapidly from our body.

In addition to the timing and other above mentioned factors, the age, gender, weight, diet and the prevailing health conditions of an individual are likely to affect the process in which a medication works. In effect, the prescribed dosage of any specific medication depends on the clinical tests performed before marketing the drug to assess the efficacy of the medication in some thousand people. Till some years back, majority of medicines were experimented on males who were either young or middle-aged. Identifying the disparities of the effect of the medications between the two sexes as well as in people belonging to different age groups, the scientific community has presently included a few aged adults as well as women in the clinical trials conducted before marketing any drug.


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