Generic Drug: Questions and Answers?

• Generic Drug Introduction
• Are generic drugs safe and reliable?
• Why are generic drugs cheaper?

Four most frequently asked questions are answered in this reading. Questions are:a)What Does Bio-equivalency mean? b)What Generic Drugs Are? c) Are generic drugs as safe and effective as their brand? d)Why Generic Drugs Are So Cheap?

What Generic Drugs Are?

Generic Drugs (or Generics) are the identical drugs of the Brand Drugs. A generic drug contains same chemical ingredients to its brand drugs. According to FDA, generics are identical or bio-equivalent as the brand drugs. Hence, generics are equally effective and exactly same in dose, intake manner and working mechanism (i.e. Pharmacokinetics) when compared with brand drugs. Generic drugs can only be manufactured and produced when patent of counterpart brand drug have expired.

Are generic drugs as safe and effective as their brand?

Yes. Because of exact bio-equivalency they produce same effects and side effects.

What Does Bio-equivalency mean?

Bio-equivalency means these similarities (between generic and its brand drug)

Active Ingredient: Generic drugs must have same active ingredient as that of brand drugs. For example, Nexium has esomeprazole magnesium as active chemical ingredient and its generic drug (Sozo) also has esomeprazole magnesium.

Indication: Generic drug is used to treat same health condition for which brand drug is indicated for.

Therapeutic Effects: Effects of generic drugs are same as that of its brand drug. Applicant generic manufacturer has to prove that to FDA with results of clinical trials.

Dose: Same dose produces same effects (including side effects) when compared to effects of dose of brand drug. Effects of Lytorin 20mg must be same to Lipitor 20 mg. FDA won't approve Lytorin 40mg as generic of lipitor if its 40 mg tablets' effects are same as Lipitor 20mg.

Working Mechanism: Mechanism of generic drug, such as release of amount of active ingredient in body and time taken to release must be same to its brand drug.

Strength of tablets (5mg, 10 mg etc): Strengths of generic drugs matches the strengths of brand drugs.

Form (Liquid or tablets): Generic medication is also in tablets form if its brand equivalent is in form of tablets.

Dissimilarities: Color, taste, size, shape and name of generic drug tablets are different from its brand tablets.

Why Generic Drugs Are So Cheap?

Because of the patent protection no other companies can produce (During patent period) a drug which is similar in color, shape, size and taste. As soon as patent gets expired patent holder company loses exclusivity to make that drug. Other pharmaceutical companies start to produce generics (But can’t without approval of FDA). As there is no-patent protection and competition, generic form of brand drug is available at extremely low cost.

Manufacturer of generics don't have to spend on research & development, marketing. All they have to do is assure government authority, with result of clinical trials, that the drug is identical in all manners to its brand drug. This save huge amount of money of high expenses. Cost of generic drugs doesn't include expenses of discovering unique medication formula and salaries of doctors and scientists.

Generic drug producers must prove that their generic version is bio-equivalent of respective brand drugs.

USA Drug consumprtion

Brand pills, 56 %
Generic pills, 44 %