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admin | Category: What Cause Ed | 25.02.2014
Generic Drugs - What are Generic Drugs?A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection.
The Japanese pharmaceutical market records annual sales of $64.5 billion each year, which is the second highest in the world after the US.
The Japanese pharmaceutical market is the second largest pharma market in the world following on the close heels of the US. The hurdles that generics faceAlthough the Japanese pharma market is large and offers huge potential for generics, it comes with several challenges for generic companies. Less costly drugs are associated with lower quality in Japan and this means that generic drugs are generally regarded as inferior to their branded equivalent. This attitude of the Japanese people have led the country's generic drug manufacturers to suffer from low public esteem and recognition in comparison with innovators.
Generics do a balancing act between growth and hindrancesThe Japanese governmnt is providing additional premiums for dispensing of generic drugs and is also planning to review its health insurance reimbursement. Reproduction in whole or in part in any form or medium without written permission is prohibited.
This May 31, 2012 file photo shows a man leaveing a 7-Eleven store with a Double Gulp drink, in New York. Ron Kitt stands near his flower stand in front of the Federal Center South West Metro stop in Washington, Friday, Oct.
UBC pharmaceutical students and a local Shoppers Drug Mart pharmacist will help to answer these questions and many more! The generic drug may still have a patent on the formulation but not on the active ingredient. Moreover, Japanese consumers only trust the brands they know (specifically, Japanese brands) and are skeptical about the efficacy and safety of drugs, particularly if they have been manufactured in countries such as China, India, which are notorious for their drug counterfeiting activities. Furthermore, the Japanese believe that the reduction in out-of-pocket expenses in buying generics is not sufficiently high to justify switching away from the brand.
These initiatives are expected increase the demand for generics in the dispensing pharmacy market. Please be sure to open and click your first newsletter so we can confirm your subscription.


This scenario is gradually changing due to several reasons such as patent expirations of drugs, a rapidly aging demographic, wideranging government initiatives to reduce healthcare spending, and comparatively high reimbursement prices. Individuals in Japan choose quality over price and this mindset remains ingrained in Japanese consumers across all industries, including the life sciences. Another major problem with this mindset among Japanese is that if patients still believe that generics are a lower quality alternative, it will take more than a relatively modest increase in cost to persuade them to switch to generics. Although the generic drug market has entered the growth stage, it has become more competitive with new entrants. Moreover, the drug price war in Japan has intensified with respect to long listed products (LLP). In December 2012 the Central Social Insurance Medical Council said that a new pricing system for generics would be introduced to help reduce their prices.
This will apply where the replacement of long-listed products by generics does not happen within a pre-determined period after the patent expires. The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents.
Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them.
For example, Thailand has imported millions of doses of a generic version of the blood-thinning drug Plavix (used to help prevent heart attacks), at a cost of 3 US cents per dose from India, the leading manufacturer of generic drugs. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of new medicines which most generic companies cannot afford to do. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug.
Competition is also seen between generic and name-brand drugs with similar therapeutic uses when physicians or health plans adopt policies of preferentially prescribing generic drugs as in step therapy.
With multiple firms producing the generic version of a drug the profit-maximizing price generally falls to the ongoing cost of producing the drug, which is usually much lower than the monopoly price.
After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug.


Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.
This may involve aggressive litigation to preserve or extend patent protection on their medicines, a process referred to by critics as a€?evergreeninga€?. Patents are typically issued on novel pharmacological compounds quite early in the drug development process, at which time the a€?clocka€™ to patent expiration begins ticking. Later in the process, drug companies may seek new patents on the production of specific forms of these compounds, such as single enantiomers of drugs which can exist in both a€?left-handeda€? and a€?right-handeda€? forms, different inactive components in a drug salt, or a specific hydrate form of the drug salt. These sorts of patents may later be targeted for invalidation (a€?paragraph IV certificationa€?) by generic drug manufacturers. In effect, Cephalon was able to extend its exclusive right to manufacture Provigil even though Cephalon's patent for Provigil had already run out. Reddy's simvastatin even show Merck as the actual manufacturer and have Merck's logo on the bottom. The FDA requires the bioequivalence of the generic product to be between 80% and 125% of that of the innovator product. These studies compared the absorption of brand name and generic drugs into a persona€™s body.
The average difference in absorption into the body between the generic and the brand name was 3.5 percent and is comparable to differences between two different batches of a brand drug Bioequivalence, however, does not mean that generic drugs must be exactly the same (a€?pharmaceutical equivalenta€?) as their innovator product counterparts, as chemical differences may exist (different salt or ester a€“ a a€?pharmaceutical alternativea€?). Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level.
A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was considered safe.
In spite of the study, many physicians are not comfortable in allowing their patients to take the branded generic equivalent agents. The initiative will use existing resources to help FDA modernize and streamline the generic drug approval process.




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