What Product-Life Cycle Management Strategies Could Be Used To Extend The Life Of A Pharmaceutical Drug?

Posted by David Watt

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WS-12-2013_47Name brand (Innovator) pharmaceutical companies must extend the product life cycles of drugs to maintain profits, exclusivity, market share and transition into next generation products. Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity to sustain drug prices, recoup research and development costs and to fund the development of new products or next generation drugs.

As with other inventions, pharmaceutical products are entitled to patent protection if they meet certain criteria. Unlike other products, drug products undergo a strict regime of test and evaluations to determine their safety, quality and efficacy before they can be distributed and sold commercially. The testing of new drug products is rigorous, costly and time consuming as lengthy clinical trials are required for new drug applications. Once the development work has been completed, the patent and new drug application can take a significant amount of time to be reviewed and ultimately approved or denied.

Our clients come to us seeking advice on options to potentially extend or augment patents and life cycle management. With diverse experience in the pharmaceutical industry, we have been able to provide a number of viable options to our clients.

Consider The Way Your Product Is Manufactured And Formulated

ID-10073775Examination of the manufacturing process can be a good starting point when seeking out the innovation that could lead to a potential patent and can add many years of market protection and exclusivity.

  • Is there something within the tablet such as a component (excipient) that imparts a unique characteristic to its performance? This could be a unique method of targeting a specific binding location or target selection site in the body. An example of this could be to coat an uncoated tablet with a functional coating system that would impart a greater degree in precision in targeting the area in the gastric system to increase the bioavailability to the blood stream and thus creating a more effective product. Targeting sites for better bioavailability can also lead to decreasing the dosing regimen for a potentially safer, more efficacious product.
  • One may examine the potential of over-encapsulating a tablet product to change the delivery system of the drug product.

 A change in formulation to stay within SUPAC Guidance may also lead to a performance change that could lead to a new patent. Excipients’ ratios may be changed by a small amount and result only in a CBE-30 filing; examples of this could be a small change in a rate-forming polymer to either extend or retard dissolution and ultimately change the delivery system of the drug.

Take A Closer Look At Your Product's Packaging Components

Packaging changes may also be examined to extend life cycle of drug products, typically these are changes to physician samples that lead to better patient compliance. Typically physician samples of solid dose products are dosed in single blistered units. If, for example, a seven day regime is given to the patient, then multiple units are provided. By moving to a seven unit blister or a 7 count bottle may assist the patient to adhere to the regime. In addition, by moving to the alternate packaging format, cost efficiencies may be identified.

Implementing Product-Life Cycle Strategies Will Ensure Market Exclusivity

Being aware of the product life cycle is crucial in projecting when Generic Pharmaceutical companies will prepare and have a generic ready to jump into the market. Generic products will have a huge detrimental effect on sales. There are a few ways that this scenario can be managed.

  • By working with the generic company on development agreements for next generation products with the agreement that the generic company delay the release of the generic drug.
  • By creating a generic subsidiary of the innovator, poised to come out with their own first to market generic, can assist in some recuperation of potential lost revenue to the generics.
  • It is best to be aware of the trends/sales in the market place and be cognisant that Generic companies will be examining these trends to determine if a competitor will be developed.

Innovator companies must work with their contact pharmaceutical manufacturers to assist in the development of strategies to extend product life cycles to ensure market exclusivity for as long as possible.

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Topics: Quality & Regulatory

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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