LCM strategies range from new indications to end of life cycle Rx-to-OTC switching strategies. The evidence supporting these strategies is typically generated through phase IIIb, phase IV, and research studies and the outcomes require regulatory approval prior to commercializing these opportunities. Multivariate strategies can be adopted depending on the life cycle stage of the product and the availability of resources. LCM strategies, if successful, can offer new solutions, create switching costs, and increase the lifetime value of the product. The following are the most common LCM strategies to create incremental value for the product.
- New indications: Identifying new pathological indications that can be potentially targeted with the same MOA. If successful, the new indications often allow companies to gain further extension of patent life.
- Reformulation/Combinations: Developing reformulations, like extended release, transdermal, intravenous medications, and fixed-dose combination products that are relatively common will offer broader solutions to patients and hence wider usage.
- Next Generation Products: Developing next generation products with better safety and efficacy profiles and one that can replace existing product revenue streams, in turn enhancing the overall product life cycle (e.g., Astra Zeneca has successfully replaced Prilosec with Nexium by launching it a couple of years before Prilosec‘s Loss of Exclusivity or LOE).
- Subpopulation Studies: Generating compelling evidence on the drug’s effectiveness in different subpopulation groups (e.g., kids, adults, Hispanics, African-Americans) will provide a channel for pertinent and persistent use by a particular subpopulation.
- Authorized Generics: BioPharma companies can launch authorized generics at the end of patent life cycle under a private label to compete with the generics. Authorized generic is normally launched around patent expiration timeframe to generate incremental revenue, thus warding off other potential competitors and prolonging the shelf life of the product.
- Rx-to-OTC Switching: It is possible to convert some prescription products into over-the-counter (OTC) products, the requirements of which are explained later in this section. Conversion of a prescription drug to over-the-counter medication increases overall accessibility and hence the broader utilization of the product. Any such change should be effected around the patent expiration time too.
Diagnostics/Devices: A drug in combination with the diagnostic and/or device offers better treatment in certain diseases and conditions. Both diagnostics and devices can offer complimentary solutions to treating patients. For example, a good diagnostic test that identifies patients with a particular mutation will allow the providers to use the best drug that targets that mutation which is necessary to improve the quality of care. Similarly, a device and drug combinations today offer the best treatment solutions to diabetic and asthma patients. Implementing any such design to improve diagnosis and management of the disease will enhance a product’s market presence rapidly.