“We next discuss a comprehensive database that we have assembled, which includes more than four hundred prescription pharmaceutical reformulations from 1995 through April 2009 … twenty- two reformulations involved switches to extended-release products or combination products in advance of generic entry for brand products with an additional $15.8 billion in annual sales.”
–Shadowen, et al, Anticompetitive Product Changes in the Pharmaceutical Industry (October 10, 2010). Rutgers Law Journal, 2009; 41(1-2)
The term “controlled release” is taking on a new meaning. At Orbis Biosciences®, we use our Precision Particle FabricationTM technology to exploit the benefits of creating microsphere-based reformulations of existing drugs. A controlled-release drug reformulation can improve the product efficacy and extend patent protection.
An important controlled-release drug reformulation improvement is mitigating the initial burst of the drug, which extends the drug’s effective duration. Immediately following administration of conventional delivery methods, there is often a burst of medicine, which then gradually wears off. Controlled-release drugs deliver medicine precisely and continuously during a longer period of time, sometimes weeks or months. This consistent, prolonged delivery of medicine results in better patient compliance because patients do not require multiple administrations. The reduced administration frequency lowers administration costs for patients and physicians. Controlled-release formulations are also safer, thanks to a decrease of side effects related to dangerous spikes in drug concentrations. All of these demonstrate that a controlled-release drug reformulation can be a superior product when compared to the original drug.
A controlled-release drug reformulation can also extend patent protection. Because market exclusivity granted by the FDA upon a drug’s approval can last for only six months to seven years, depending on the type of exclusivity granted, most companies file for patents. A patent expires 20 years after its filing date. After a patent expires, other companies can make and sell lower-priced, generic versions of the drug. According to US Pharmacist, these generic versions can eventually account for up to 90% of a drug’s sales, which results in a strong reduction of revenue for the company with the proprietary drug. One way to prevent this loss of sales is to file for new patents for drug and delivery reformulations, such as controlled-release versions. An additional benefit of controlled-release drug reformulations is that the time to FDA approval is shorter than it would be for a new drug because it can be compared to the existing market formulation.
By reformulating a drug into a controlled-release version, a company can improve its product efficacy and extend patent protection, and the Precision Particle Fabrication technology is a great vehicle to do both of these things. With Precision Particle Fabrication technology, Orbis Biosciences is redefining control. The term “controlled release” will never be thought of the same way again.