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Elizabethton Veterinary Clinic

Article Written by:  Dr. Michael Brown -  Elizabethton Veterinarian Clinic

Our Paws Newsletter by Elizabethton Veterinarian Clinic


From a professional medical point of view, this year will be interesting because it is expected that multiple new flea, tick, and heartworm products will be released. As the companies that did the research and development of the various products lose their patents on their products, other companies will copy the product and some of the new products will be sold as ‘over-the-counter’ variations of the original product. It takes millions of dollars and multiple years for a drug company to develop a new drug, test the drug, research the drug, and prepare the drug for FDA approval. If the FDA does approve the drug, the company is granted a patent on the drug for a limited amount of time. The drug company then has to guess about how much of the product that they can sell in the limited time (usually seven years) that they have an exclusive patent and then set the price of the drug to try to recoup their investment within the life of the patent. Once the patent period has expired, any other company can copy the drug and produce the drug without the expense of the research. Note: there are some ‘special use’ and ‘rare use’ drugs for which this generalization does not apply.

The company that is copying a previously patented drug knows all the chemicals and ingredients in the drug but does not necessarily know the production process. For instance, if two people were each given all the ingredients to make a cake but only one of the individuals was given the mixing and baking instructions it is unlikely that both cakes would turn out to be identical. By chemical analysis, both cakes would contain the same ingredients; but, the cakes would not necessarily be identical and would not necessarily look the same nor taste the same. The same concept applies to the ‘copy-me’ drugs – they may or may not do the same job as the original patented drug although the chemical ingredients may be identical

It is not unusual for a generic drug to be less effective in some of its design parameters than the original patented drug. On the other hand, many generic drugs are as effective and as safe as the original product. Many of the generic products are as effective as the original patented product in most circumstances but not in all circumstances. As the generic products are not subjected to the rigorous research as was the original product, no one knows how effective or how potentially harmful the generic product will be until it has been on the market for a while and hundreds of thousands of patients have used it – successfully or unsuccessfully. In my 43 years of practice experience, I have seen dozens of ‘copy-me’ generic products fail – some simply did not ‘do the job’ and others were harmful under certain circumstances.

Therefore, this practice will not recommend any of the new generic products until a given product has been sold on the market long enough and has enough safe usage history that we believe that it is equivalent to the original product. We do this for the safety and protection of our patients. The single value of a generic product over the patented product is that it is usually cheaper than the original researched product – sometimes substantially cheaper. The primary problem with a new generic is that no one is quite sure how it will perform in the mass market when you consider all the variables of pets of different breeds, different levels of nutrition, different disease conditions, different genetic codes, different housing conditions, different ages, pregnant or not, other drugs being taken, etc.

We expect some of the new products to succeed, some to be marginal, and some to fail. We are not willing to subject our patients to the trial and error process of non-researched products. There are enough others out there that are willing to ‘try it’ to save a few bucks. We will let others ‘try it’ and if the new product has advantages (usually price) and no disadvantages when compared to the original patented product, we will then make professional recommendations accordingly.

The concept in this newsletter is why prescriptions written or called into a pharmacy by a veterinarian/dentist/physician contain the question “generic substitutions allowed?” It is the professional’s “call” to determine the safety and efficacy of the generic product under the specific circumstances of the patient. Perchance you want to discuss this subject further, please call our office during normal business hours for an appointment.

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