July 28, 2011

When a drug manufacturer  (a pharmaceutical company) creates a new drug, it must be thoroughly tested and approved before it is sold. The U.S. Food and Drug Administration (FDA) regulates and approves new drugs. Because many new drugs never make it through the development and approval process for various reasons, when a drug company does obtain approval for a new drug, it must price the new drug to recoup its costs in bringing the drug to market as well as make a profit from the sale of the new drug. The government makes sure that there are incentives for drug companies to develop new drugs by granting patent protection to the drug manufacturer that precludes other drug companies from manufacturing and selling the same drug. Drug patents typically last for 20 years after which the patent protection expires and generic drug manufacturers may begin to manufacture equivalent drugs called generic drugs. 

Generic drugs are identical to brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use, and are chemically identical to the brand name drugs. The FDA requires that generic drugs have the same high quality, strength, purity, and stability as the brand name drugs and that generic drugs must perform the same way as their brand name equivalents. Generic drugs must also be approved by the FDA before they are sold to the public (generic drug manufacturers must complete an abbreviated new drug application (ANDA) in order to obtain approval to sell a generic drug, which process does not require the generic drug manufacturer to repeat the costly animal studies and clinical research on the ingredients and dosage forms that the FDA already approved for safety and effectiveness for the brand name drug).

To gain FDA approval, a generic drug must contain the same active ingredients as the brand name (the inactive ingredients need not be the same); a generic drug must be identical in strength, dosage form, and route of administration; a generic drug must have  the same use indications; a generic drug must be the bioequivalent to the brand name drug; a generic drug must meet the same batch requirements for identity, strength, purity, and quality; and, the generic drug must be manufactured under the same strict standards of the FDA’s good manufacturing practice regulations for brand name drugs.  

Since the approval process for generic drugs is less intense and less costly than for the brand name drugs, generic drug manufacturers can typically sell their generic drugs at much lower prices. Generic drugs sold at retail pharmacies save consumers an estimated $8 to $10 billion per year, with more billions in savings when hospitals use generic forms of drugs.

Source: FDA

Since new drugs are being constantly developed, FDA-approved, and patented, brand name drugs come off patent (that is, the patent expires) every year. In 2011, it is anticipated that at least 15 brand name drugs will come off patent for which generic drugs may be offered for some of them (not all brand name drugs have generic drug equivalents). Some of the brand name drugs that may have generic equivalents come to market during 2011 include Levaquin, Zyprexa, and Lipitor. Source

If a brand name drug or a generic drug caused injuries to you or a loved one, you may have a valid medical malpractice claim or product liability claim. Many of our medical malpractice lawyers also handle cases involving injuries caused by drugs. Visit our website to be connected with medical malpractice lawyers in your area who may be able to assist you with your claim or call us toll free 800-295-3959. Turn to us when you don’t know where to turn.