After Patent Life, FDA says NO to Generic OxyContin

After Patent Life, FDA says NO to Generic OxyContin



Under the Food, Drug, & Cosmetic (FD&C) Act and implementing regulations, the Food and Drug Administration (FDA) is responsible for ensuring that all new drugs are safe and effective. FDA also regulates the advertising and promotion of prescription drugs under the FD&C Act.


Purdue Pharma L.P., based in Stamford, CT, is a privately held pharmaceutical company founded by physicians. The FDA approved Purdue Pharma’s controlled-release pain reliever OxyContin in 1995. OxyContin (oxycodone hydrochloride controlled-release) is an opioid analgesic supplied in various dosages for oral administration. OxyContin is Purdue’s brand for time-release oral oxycodone. OxyContin followed Purdue’s older product, MS Contin, a morphine-based product that was approved in 1984 for a similar intensity and duration of pain and during its early years of marketing was promoted for the treatment of cancer pain.




OxyContin’s time-release formula could be used over 12 hours to maintain a steady level of the narcotic oxycodone in patients suffering from moderate-to-severe pain. By 2001, sales had exceeded $1 billion annually, and OxyContin had become the most prescribed brand name narcotic medication for treating moderate-to-severe pain. OxyContin has long been one of the nation’s top-selling prescription painkillers with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.


However, in early 2000, reports began to surface about abuse and diversion for illicit use of OxyContin. Several factors thought to be early contributors to the abuse and diversion of OxyContin are: 1) the active ingredient in OxyContin is twice as potent as morphine, which may have made it an attractive target for misuse; 2) the original label’s safety warning advising patients not to crush the tablets because of the possible rapid release of a potentially toxic amount of oxycodone may have inadvertently alerted abusers to methods for abuse; and, 3) the significant increase in OxyContin’s availability in the marketplace may have increased opportunities to obtain the drug illicitly in some states.


After the problems with often-abused OxyContin began to surface, FDA and Purdue collaborated on a risk management plan to help detect and prevent abuse and diversion. Although risk management plans were not in use when OxyContin was approved, they are now an optional (or, at times, required) feature of new drug applications.


Recent Developments


Purdue stopped making its classic OxyContin pills — first released to the market in 1995 and easy to crush, snort and abuse — in 2010. In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Purdue stopped shipping original OxyContin to pharmacies in August 2010. Various sources estimate that this new ‘tamper-proof’ pill’s patent term will expire about 2025.


Purdue Pharma’s patent on its original OxyContin formulation expired on April 16, 2013. That very same day, the FDA issued an immediate press release stating that it will not approve generic formulations to the original OxyContin. The FDA says that:


“because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”


The FDA also approved updated labeling for Purdue’s reformulated OxyContin tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).


The decision is the first time that the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton. Dr. Throckmorton further stated that the F.D.A. had looked at data from several studies, some of it underwritten by Purdue, in arriving at its decision. He said that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.




The public health position is clear. Dr. Throckmorton says that “[t]he development of abuse-deterrent opioid analgesics is a public health priority for the FDA.” The public health aspect is self-evident, but what about the ramifications of the FDA’s decision?


Pharmaceutical companies invest vast sums of money into their Research & Development (R&D) programs, including safety and efficacy testing. The exclusive monopoly of a patent offers these companies means to recoup some of that investment while also promoting the progress of science and providing full disclosure of the invention (which in this case is a composition of matter). Typically, when a drug loses patent, revenues plunge quickly because such expirations open the door to a slew of cheaper versions from generic drug manufacturers that can rely on abbreviated new drug applications (ANDA) containing safety and efficacy data previously submitted to the FDA.


In general, generic drug companies are not built upon the model of conducting extensive R&D. It is this axiomatic principle that the FDA decision effectively protects Purdue from lower-price competition by requiring generic companies to develop their own abuse-deterrent designs. The ‘catch 22’ here is that generic drug companies, in part, are able to offer more competitive drug pricing because of the ANDA’s cost-saving reliance on the brand-name drug’s safety and efficacy data that was already submitted to—and relied on—by the FDA.


Economics teaches us that when supply is limited and demand outpaces supply (which it undoubtedly has for OxyContin), the price for goods generally increases. So, too, is the case with reformulated Oxycontin. When reformulated OxyContin was introduced to the market in late 2010, the price of the new version of OxyContin was about $6 per 40 milligram tablet, the same then as the price for the non-tamper resistant pill. Since then, the price of the new version has risen to about $6.80 for a tablet of that strength. Roughly a 13% increase in product price in less than three years of being on the market is not too shabby for Purdue’s profits.




Reformulated Oxycontin adds greater understanding of the affects and interplay between law and economics. The advertisement-like, ‘all-new’ OxyContin is a strikingly, interesting demonstration of the interconnection of patent law, food & drug law, public health, pharmaceuticals, and marketplace economics. Metaphorically-stepping back from the trees to see the entire forest is an invaluable lesson.