Just a year back, my friend was diagnosed for hypertension and after a detailed discussion with her doctor they decided to start her treatment. Initially, her doctor prescribed her a drug with brand name Lopressor for 2 weeks. When she reached the pharmacy to get the drug, she found out that the cost of the drug is little too high, she enquired that whether there is any alternative for less cost. The pharmacist said that the drug Lopressor is available in generic form, metoprolol, that is much less costlier, but the doctor has to approve its use. When consulted, the doctor approved the use of that drug, but my friend was surprised to find that the shape and the color of the drug was different from Lopressor. She was completely frustrated and confused that whether this is the same drug? Or whether she should have stuck with the brand name drug that doctor prescribed earlier? And many more such questions lingered around her mind. I understand, many of us would have experienced such situations not knowing what is right and what choice to make when it comes to medicines.
As drugs are medicines that cure our illness care must be taken in choosing the best one. Go on with the article to know why there were two different kinds of drugs prescribed to my friend, how can one drug be substituted for another and what exactly brand name and generic name refer to?
Brand name drugs
There are many prescribed medicines in the market for a particular disease. A brand name drug is the one that is discovered, developed, and marketed by a pharmaceutical company. Once an effective drug is discovered the company immediately files for patent to prevent other companies from making or selling the same drug. The discovered drug is initially given a chemical name that represents the atomic or molecular structure of the drug. But this is too complicated for general use. Therefore, when the drug is approved by the Food and Drug Administration (FDA) it is given two names a brand name and a generic name. The brand name or the trade name is the one that the company gives while applying for patenting. It represents the company’s request for approval of the drug and is identified as the exclusive property of that company. For example, the drug for pain reliever is Tylenol, which is the brand name and the same drug is called as acetaminophen in its generic form. The brand name drug for diabetes is Glucophage and the generic drug is metformin.
Generic drugs
The company that applies for patent for a newly discovered drug can sell and market the drug under brand name only till the patent is available. Once the patent expires, the same company or some other company files submission to regulatory authority for approval to market and sell the same drug but under different name called the generic name. Patent period for every drug varies, for some drugs it may be up to 20 years and for some it may be 10-15 years. Generic drugs are sold substantially at a lower cost than its brand name drugs that is why the insurance always encourages using the generic version of the drug.
Are the ingredients in generic different?
No. The generic version of a drug has the same active ingredients, same dosage, intended uses, same effects, same side-effects, same route or administration, similar risks, safety, and strength that of its branded counterpart, which is approved by the FDA. The pharmacological effects are same as that of the branded one. Generic versions are equally potent as its branded counterpart. Generic versions are available for many important drugs in the market. But they are sold at a significantly low price than the branded drugs.
Why do generics look/taste different?
Every drug, whether branded or generic, is made up of two different ingredients – the active ingredients that functions to treat the disease and the inactive ingredients that is responsible for the color and taste of the drug. The FDA recommends that the active ingredients in both branded and generic drug should be the same, however, the non-active ingredients may differ making the drug look and taste different. Be sure that the generic drug has the same pharmacological effects as its branded counterpart regardless of its shape, color, size, and taste.
Why are generics much cheaper?
The cost of generic drugs is so cheaper that it has become a major concern for people that whether the quality and the effectiveness of drug have been compromised to make a much cheaper version. But people need not worry as the FDA demands that the generic version should be as effective and as safe as its branded counterpart. The generic drug has not been compromised in any way from its branded one but still the difference in cost come because a company need not spend money on the discovery of a new drug, need not apply for patenting, need no preclinical tests on animals, and need not spend much on marketing the drug. The company has already spent substantial amount of money while releasing the branded version of the drug therefore brand drugs are much costlier than its generic version.
Do generics meet the same standards & are they regulated by FDA?
The FDA gives the assurance of the effectiveness and the safety of the generic version of the drug. The FDA demands that the generic drugs also meet the same rigid standards that were met for a new branded drug. The FDA approves a generic version only if it meets the following criteria
- Have the same ingredients as in its branded counterpart
- Should be similar in strength, dosage, and route of administration
- Should be used for the same purpose
- Should be bioequivalent
- It must deliver the same amount of drug into the bloodstream
- The identity, strength, quality, and purity should meet the standard requirements
- The same strict standards of FDA’s good manufacturing practice regulation that is required for branded drug should be met for its generic version also
- The manufacturing, testing, and packaging sites of generic drugs must meet the same standards as required for branded drugs
FDA permits very minute variability in purity, size, shape, color, and other parameters in the generic version. The generic version can differ in it inactive ingredients (a drug has both active and inactive ingredients like dye). But along with this, FDA also limits the range of variability in terms of composition and performance.
Conclusion
The very important part of opting for the equally effective and much cheaper generic drugs is making an informed choice. The question – whether branded version is best or it generic version is best will always be in consumers mind. This is because there are lots of false myths about generic drugs; people believe these myths and ignore the actual facts. But the decision about what is best depends completely on the doctor’s choice, the health condition, sensitivity to change in medicines, and how difficulty is it for the patient to pay the bill. Importantly, let the pharmacists know whether generic version or its branded version in fine or only branded drugs recommended for the patient.
