Oftentimes, we receive questions from our clients about generic vs. brand name drugs and the approval process associated with both. When a pharmaceutical company first approves and markets a drug, it is done so under a patent that provides the pharmaceutical company that developed the drug to sell it. There are only a few narrow exceptions in which a generic drug can be produced at the same time as brand drugs, such as if the developing pharmaceutical company’s patents are unenforceable or cannot be infringed.
The primary purpose for allowing the developing company to hold the patent on this drug before generics can begin producing the drug is to allow the developing company to regain the cost of testing, developing, approving and producing the drug. A generic company can begin producing the drug when the patent has expired. The generics can then manufacture the drug without concerns regarding the costs of approving, testing and developing that the brand pharmaceutical incurred.
The generic approval process is governed by the “Hatch-Waxman Act”, otherwise known as the U.S. Drug Price Competition and Patent Term Restoration Act. The Act was meant to expedite the availability of generic drugs by allowing the FDA to approve applications to market generic versions of brand-name drugs without incurring the costs of testing and developing the drug. The Act requires that a generic drug company file an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration, in particular, the Office of Generic Drugs. Within the ANDA, the generic drug applicant must demonstrate that their product is bioequivalent (i.e. that the generic drug will perform or react within a patient’s blood stream in the same way as the brand drug). Once the ANDA is approved, the FDA adds the drug to its approved Drug Products list, also known as the “Orange Book.”
An example of a drug that has undergone the above process is the brand name drug Reglan, manufactured by Schwarz Pharma and its generic form, Metoclopramide. Metoclopramide was first developed in the 1960s. In 1979, Metoclopramide was approved in injection form. One year later, in 1980, Metoclopramide in tablet form was approved by the FDA for symptomatic gastroesophageal reflux and diabetic gastroparesis. The recommended dose is 5 to 20 mg four times daily and was approved for short-term use not to exceed 12 weeks (4-12 weeks). Currently, Metoclopramide is manufactured by a large number of generic manufacturers, including, Alaven Pharmaceuticals, Teva Pharmaceuticals, Pliva, Inc., Actavis Inc., Barr pharmaceuticals, Purepac Pharmaceuticals, Ranbaxy Pharmaceuticals, Qualitest Pharmaceuticals and Mutual Pharmaceuticals. Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders such as tardive dyskinesia. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. These studies prompted the FDA to issue a black box warning in February 2009 regarding the increased risks of tardive dyskinesia associated with Reglan or Metoclopramide exposure longer than 12 weeks.