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Friday, March 17, 2017

All you Want to Know About Generic Drugs but were Afraid to Ask


When I was still employed by FDA ( 1990-2002), I have numerous contacts with other chemistry reviewers and team leaders from our Division Of Generic Drugs. Thus I did have knowledge that if a drug is approved by the Generic Drug Division, it will be as effective, safe and of the same quality as the brand name drug, but it will be definitely cheaper in cost. Thus if my physician changed my prescription to the Generic version, I have no problem with it. However, I have friends and relatives who still believe that the generic version of the drug is inferior than its brand name, thus they are cheaper. Unlike dietary supplements, generic drugs are approved by FDA prior to marketing.

Just recently, one of Macrine's prescription drug for her PD was changed to a generic version which was a hundred time cheaper than the brand name drug. The brand name drug was very, very expensive I have to purchase it via Mail through my Federal Insurance Mail Prescription Benefits. The brand name was Azilect and the Generic version is Rasagiline. Here's the announcement of the approval of the generic version of Azilect on March 17, 2016.

"The U.S. Food and Drug Administration approval of rasagiline was announced by its manufacturer, Orchid Pharmaceuticals. Rasagiline, is the company’s first AB-rated generic for Azilect (Teva Neurosciences) tablets, indicated for the treating of Parkinson’s disease.

The drug works by blocking the activity of monoamine oxidase-B (MAO-B), an enzyme that breaks down dopamine, which therefore helps to stabilize blood levels of dopamine. It is important that dopamine levels are regulated because low dopamine levels, may lead to problems with balance, movement, muscle control, and other symptoms of Parkinson’s.  The recommended dose of Rasagiline for the treating of Parkinson’s is once daily either alone or in combination with levodopa, another Parkinson’s medication.

Orchid Phamaceuticals plans to introduce Rasagiline to the U.S. market in the third quarter in 2016. Orchid has a 180-day exclusivity period for Rasagiline. Global sales for Azilect in the year 2015, was approximately $514 million, according to Teva Neuroscience’s annual report".

But why are Generic drugs cheaper than the brand name drugs, let me explain. But first here the official definition of Generic Drugs.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

Generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect. This patent will last from 17 to 20 years depending on the date of approval.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

There is no truth in the myths that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.

Another common misbelief is that generic drugs take longer to work. The FDA requires that generic drugs work as fast and as effectively as the original brand-name products. This is called the Bioequivalence Studies.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

References: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Generic Drugs: What you need to know, 2009 and http://www.medicinenet.com/script/main/art.asp?articlekey=46204&page=2

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