D I S S E C T I N G B U S I N E S S
Patents encourage investment in new drug development , while their expiration makes life-saving medicines more affordable .
This raises an important question : how can manufacturers manage patent cliffs to sustain their business and continue providing lifesaving medications ?
Managing product lifecycles
Pharmaceutical companies use several common strategies to manage the challenges to an injectable form to reach more patient groups . Constant reinvention also allows companies to provide high-quality , best in class products .
A different approach involves expanding the use of an existing drug to treat a new patient group , which can result in additional approved indications . For example , the diabetes drug Ozempic was further developed and studied in other patient groups , eventually launching as a treatment for obesity , which helped secure extended patent protection .
Logistics after patent expiration
As drugs reach the end of their patent life , a thorough review and adjustment of logistics becomes essential to adapt to the new reality of increased competition .
Diane Onken , Head of Sales at Americas at Envirotainer
One key consideration is likely changes in shipping volumes in line with new market conditions . The intense competitive landscape post-patent expiration puts even greater pressure on finding cost-effective solutions that do not compromise product integrity . Manufacturers might look for lightweight , durable packaging that maximises cargo space as this will help reduce shipping costs without sacrificing product protection . of patent cliffs . One approach is to time new product launches to coincide with the patent expiration of existing products , maintaining a steady income .
But this strategy is fraught with challenges because of the unpredictable nature of drug discovery and development . Developing a new drug is a high-risk , high-cost endeavour , with only one in 500 drugs making it to market . The extensive research , clinical trials and regulatory approvals required often take over a decade and cost billions . Aligning product launches with patent expirations , while ideal , is easier said than done .
Another strategy is to further develop the existing drug to extend its lifecycle . For example , companies can develop new formulations or delivery systems for existing drugs , such as shifting from an oral tablet
While high-performance solutions are vital throughout a drug ’ s lifecycle to maintain product quality and patient safety , packaging choice may also be guided by stability data and risk assessments depending on the stage of the product being shipped .
For example , a product being newly introduced to the market may have little stability data available or may be shipped on a relatively unknown tradeline . In such cases , a solution with real-time monitoring is crucial for immediate intervention should the unexpected occur , helping maintain temperature control , product efficacy , and cost-effectiveness . This approach can also accelerate time-to-market and provide a competitive edge .
In contrast , a mature product approaching patent expiry may have a well-established shipping history and extensive stability data so its behaviour during transit is far more predictable . In this instance , a solution
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