A Branded drug company invests big money on the research and development of a fresh drug. Following the discovery of a lead mixture and before conducting the clinical studies, the company can obtain a patent. Once the patent is obtained, the business gets exclusive rights to create the drug and exclude others from processing the drug. The branded drug company looks forward to the monopoly of processing and marketing the drug before patent expires. The expense of a branded drug is high as the company tries to recover the money committed to the research, development and marketing of the drug. Once the patent has expired. , common drugs type in to the market. Are these generic drugs as effective and safe as the branded drugs? Yes these are. Then why are they so much cheaper than the top quality drug? Because, unlike the top quality drug company, general drug companies need not invest a lot of money on research and development and their overall investment in bringing the drug in to market is very less set alongside the top quality drug. As generic drugs are as effective and safe as the top quality drug and relatively cheaper than the branded drug, patients like them. This brings about a street to redemption in the top quality drug market which eventually brings about a street to redemption in its price because, market conditions such as, quantity of sellers, barriers to entry etc. determine the level of competition in a market. Some companies stay away from this by various methods. Among such methods is "Evergreening of patent".
There is an extended standing debate on whether generic drugs are as effective and safe as the top quality drug. A brand name drug is a remedies that is observed, developed, and promoted by a pharmaceutical company and is protected by the patent. A universal drug is reported to be a bioequivalent of the branded drug and does not have a patent by it self and it is manufactured and promoted only following the expiration of the branded drugs patent. Brand name drugs are well known and respected but are expensive. Generic drugs are less costly than the brand drugs but drugs aren't always respected by individuals. How ever, the final decision to choose a brand name medicine or a generic drug involves both the patient and the health care team.
According to Howland(2010), "The concept of bioequivalence is used by the U. S. Food and Medication Administration, (FDA) to judge and approve common drugs without additional security and effectiveness studies". As per FDA, generic drugs should have the same active component, dosage strength, option of administration and really should be the same dosage form as that of the brand name medicine even though they have got different inactive elements and look not the same as the branded one. All universal drugs are tested for safety, effectiveness and bioequivalence with the brand drug before they are really approved by the FDA and promoted. But the branded medicine is of higher cost than universal drugs. Most people don't realize that, when they buy a branded medication, they may be not merely buying that medication however they are also spending money on what it had taken to build up that medication and marvel, "why branded drugs are so expensive than the generic drugs?" The higher cost of the top quality drug is because of the top investment in research and development by the business and universal drugs doesn't need this investment and hence they can be so cheaper.
It requires about 10-15 years to find a medication, develop it and make it available for sale for dealing with the patients. The average cost of this whole process is approximated to be $800 million to $1 billion. This includes the expense of thousands of failures. For each 5, 000 to 10, 000 ingredients, that enter the research and development, only 1 receives approval. Once the medicine is approved by the FDA, the pharmaceutical company can apply for a patent. A patent provides the company, the right to exclude others from making, using, retailing, or importing the trademarked invention. In the US, patent offers a protection of 20 years, but it is applied from prior to the beginning of clinical trials. So the effective life of the drug patent could be between 7-12 years. Once a patent is obtained, the pharmaceutical company likes an interval of market exclusivity or monopoly, where the company is able to set the price tag on the drug to be able to maximize profitability. This high price can help the medication company to make a significant profit on their investment in research and development. Generic drugs can't be produced legally until the patent has expired or the generic company certifies that the brand companies patent is invalid or in countries where in fact the patent is not in force. After the patent of the top quality drug has expired, any pharmaceutical company can manufacture and sell that medication and hence common drugs come directly into play, which prevent the branded medicine company from dictating the overall market price of the drug. A generic drug must contain the same active ingredient as the original formulation. While using entry of general drugs in to the market, there will be a significant fall season in the price tag on the branded medication which is because of the low price of general drugs. General drugs save the patients and the insurance firms considerable costs.
According to the U. S. Food and Medicine Supervision (FDA), "universal drugs are indistinguishable or with within an acceptable bioequivalent range to the top quality drug with respect to pharmacokinetic and pharmacodynamic properties. " Two drugs are reported to be bioequivalent, if their rate and extent of supply after administration are similar to the magnitude that their basic safety and efficacy should be expected to be same. This implies that the common drugs are equivalent by dose, durability, route of administration, safety, efficacy, designed use and they have the same active ingredient. Legislation requires the generic medicine manufacturers to confirm the bioequivalence of these medicine with the top quality drug and the range of bioequivalence should be between 80%-125% of this of the top quality drug. Bioequivalence will not necessarily mean that the universal medication should be pharmaceutically equal to the branded medication and some chemical substance differences may can be found. Based on the Hatch-Waxman Act, an applicant should record an Abbreviated New Medication Request (ANDA) with the meals and Drug Administration and show the bioequivalence of his generic medicine with the top quality drug in order to get an acceptance. FDA, approves the medication, if it feels that the common medicine is bioequivalent with the innovator drug. Hence all the marketed common drugs are bioequivalent with the top quality medication and are therefore safe and effective as the branded drug. But in some cases, general drugs may show some undesired effects that are not seen with the branded drug. For instance, in 2007, patients who turned from an anti-depressant branded medication, Wellbutrin XL 300mg to its common version Budeprion XL 300mg experienced certain undesired effects.
The universal drugs are extremely cheaper than the top quality drugs. The main reason for such low price of generic drugs may be your competition among the medicine manufacturers when drugs are no longer shielded by patents. Generic drug manufacturers do not need to invest a lot of money in drug discovery and development. In addition they need not verify the security and effectiveness of the medicine through clinical studies as they have recently been conducted by the branded medicine companies. Hence companies incur fewer costs in producing the generic drugs. Advertising advertising and other marketing efforts by the branded medicine companies also help the common medicine companies in minimizing their investment in marketing. Many generic drugs have already been in the market for years and are well-known to the patients, but often under their top quality brands. Hence all the above facts make the universal drugs much cheaper than the top quality drugs.
Large pharmaceutical companies often spend some millions of dollars to protect their patent from common competition. Once the patent is about to expire, some patent holders try to stretch the patent by various methods. They include: taking new patents, purchasing the competitors, aggravating the competition etc. It isn't a formal idea of patent legislations, but is known as a social proven fact that is utilized by the pharmaceutical patent owners to extend their privilege of monopoly in the highly profitable branded drug, thereby protecting against the accessibility of general drugs into the market. Some times the top quality companies may use various other methods like licensing a subsidiary to market generics under the initial patent.
In specific circumstances, a patent exclusivity of 180 days and nights is provided by the FDA to the generic medication manufacturers in specific cases. During this period, only one universal drug maker can make the generic drug. This exclusivity period is offered only in cases when a general manufacturer argues that a patent is invalid or is not violated in the make of a universal drug. For instance, Simvastatin was created and promoted under the brand name Zocor by Merck & Co. When the corporation lost its patent in 2006, Ranbaxy laboratories and Teva Pharmaceutical Sectors obtained a 180 day patent exclusivity period for Simvastatin.
Finally it could be said that, generic drugs are of for the most part importance because, studies say that, common medicine substitution of prescription drugs could save $88 billion of investment property on medical care in USA. Even though there are certain exceptional cases, it can be said that general drugs are as safe and effective as the branded drug, because universal drugs are marketed only if they may be approved by the FDA to be bioequivalent to the top quality drug and they're cheaper because generic drug companies do not need to invest a lot of money on research, development and advertising of the medication. This makes the generic drugs more preferable and satisfactory by the patients and today more than 70% of the drugs promoted are generic drugs.