When a pharmaceutical organization develops a new molecule of a drug, they apply for a patent with a brand name and pharmacological properties, and this patent has a life span of two years typically. After the expiry others can produce medicine with identical features, they can enter the market as a producer of the generic drug but cannot use the brand name.
The generic medicine name usually starts with a smaller case, whereas the brand medicine name begins with a capital letter. The generic drugs can have the same composition and pharmacological properties as that of the original branded drug viz.)
- Strength and dosage,
- The pattern of use,
- Effects and side effects,
- Mode of administration,
- Precaution, risks, and safety.
A classic example of a generic drug is the ones developed after Viagra. Viagra was introduced in 1997 by Pfizer containing a molecule called Sildenafil Citrate. Even though that was developed accidentally, it proved to be the right medicine people were longing for the treatment of ED (erectile dysfunction) and impotence. The demand soured all over the globe, and naturally, the manufacturer could demand a higher price. The trend got reversed twenty years later with so many generic versions of Viagra came into existence at meager prices.
Other popular brand medicines went generic are Metformin (diabetes) and metoprolol (blood pressure).
The prices of the generic drugs are lower because these manufacturers need not spend much on research and development. But the quality and other properties are as good as the brand medicine. (As standard practice, brand names are generally capitalized while generic names are starting with small letters.) . The set standards of all drugs by the FDA demand the highest quality. Another reason why generic medicines are cheaper is that the manufacturers need not have additional promotional and marketing expenses.
The manufacturers of generic medicines approach the sanctioning authorities like FDA just before the expiry of the copyright of the brand drug. It may be a couple, or a dozen manufacturers appear simultaneously pushing down the generic drug price to a superficial level.
Generic medicines usually appear in different shape, color, taste, and packing as per the law dictate. The active pharmaceutical ingredient (API) has to be same as per the FDA. This is not strictly followed in other countries, especially on the pharmacokinetic and pharmacodynamics fronts… However, the Bioequivalence does not mean generic drugs must be identical to the brand-name product (“pharmaceutical equivalent”).