A generic medicine is the therapeutic equivalent of an originator pharmaceutical product whose patents protecting that product have expired. A generic medicine contains the same active substance as and is essentially similar in action to the originator product. Equivalent generic medicines may contain different non-active ingredients (such as colorings, starches, saccharose etc), which have no therapeutic effect. In certain cases generics and originators may also differ in salts and esters, but these must not affect therapeutic equivalence between the two products. As with all other medicines, the quality, safety and efficacy of a generic medicine is assured the relevant regulatory agencies, such FDA in the United States. Amongst other things, FDA requires that the generic medicine be “bioequivalent”, that is, “essentially similar”, to the originator product. The generic drug is scrutinized thoroughly by FDA before it is granted a marketing approval to ensure that it complies with exactly the same controls over quality, safety and efficacy as all other medicinal products. Generic Drugs are manufactured and processed at site pre-approved by FDA. Such approved sites are subject to regular FDA inspection to ensure that these comply with the “Good Manufacturing Practice”. And lastly, just like originator products, once a generic drug is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.
No!
Generic drugs are available only after the relevant patents have expired. Pharmaceutical products are covered by a number of patents, sometimes by as many as 20-40 patents or more. In addition, a patent on a “new use” can block the registration or marketing of a generic drug product for treatments where the base patent has already expired. Effective pharmaceutical patent protection is thus longer than in other industries, lasting up to 25 years in some case.
Yes! Indeed,
Generic drugs cost 20% to 80% less than the original price of their band-name equivalents. In addition, competition from rival generic products force originator companies to reduce their own prices after — or even before — patent expiry.
Wockhardt’s generic drug products are produced in the FDA approved manufacturing environment and meet all quality and safety requirements laid down by FDA. Wockhardt also understands the importance of Intellectual property in the advancement of innovation and community welfare. Therefore, Wockhardt ensures that its product do not infringe any of valid Intellectual property of other at any time. Wockhardt also cares for its customers by timely making available off-patent drug products at affordable prices.
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