The Rationale Behind Rx-to-OTC Switches

Over the past several decades, more than 600 products have transitioned from prescription to OTC status, reflecting a significant industry trend toward empowering consumers and enhancing product accessibility. This shift is driven by several factors:

• Life Cycle Management: As patents expire, Rx-to-OTC switches offer a pathway to extend a product’s market life, mitigating revenue declines associated with generic competition.
• Market Expansion: OTC availability allows direct consumer access, potentially increasing market size and product adoption rates.
• Healthcare Cost Reduction: By enabling self-medication for certain conditions, OTC products can alleviate the burden on healthcare systems and reduce costs for patients.

Identifying Candidates for Rx-to-OTC Transition

Not all prescription medications are suitable for OTC conversion. Identifying ideal candidates involves a comprehensive assessment of several factors:

• Safety Profile: Medications with well-established safety records and low potential for misuse are prime candidates.
• Consumer Understanding: Conditions that are easily self-diagnosed and managed increase the likelihood of a successful OTC status approval by the relevant authorities.
• Market Demand: Assessing consumer interest and demand is crucial to ensure the product meets an existing need in the OTC market.

Ecclis’ Expertise in supporting Rx-to-OTC Transitions

At Ecclis®, we specialize in guiding pharmaceutical companies through the multifaceted process of Rx-to-OTC switches, ensuring a seamless transition that aligns with regulatory standards and market expectations. Our comprehensive services include:

1. Market Potential Assessment: Conducting in-depth analyses to identify suitable candidates for OTC conversion based on consumer demand, market trends, and competitive landscapes.
2. Regulatory Navigation: Providing support through the intricate regulatory pathways required for Rx-to-OTC transitions, ensuring compliance with local, regional and international standards.
3. Labeling and Consumer Communication: Developing clear, user-friendly labeling and educational materials to support safe and effective use by consumers
4. Launch and Commercial Strategy: Crafting tailored launch plans to maximize impact, including pricing strategies, distribution channels, and promotional activities.

Successful Rx-to-OTC Transitions

Past approvals underscore the viability and benefits of Rx-to-OTC switches:

• Frontpro® (Afoxolaner): Originally based on prescription products within the Animal health segment, where approved for duplication, name change and non-prescription use, providing pet-owners in selected European countries with direct access to effective treatments of flea and tick infestations on cats and/or dogs.
• Benzac® Gel (Benzoyl Peroxide): Transitioned to OTC status within the Human health segment, offering Dutch consumers convenient and effective options for the treatment of acne vulgaris.

These examples highlight how strategic Rx-to-OTC transitions can rejuvenate a product’s market presence and accessibility.