More than 700 pharmaceutical products have made the switch from Rx to OTC over the past several decades. The U.S. Rx-to-OTC market has grown into a $13.8 billion market. This has mainly been due to factors such as patent expirations, increasing competitiveness with the pharmaceutical environment, the FDA willingness to work with industry, brand re-invention, consumer demand, and cost containment strategies. The U.S. market for Rx-to-OTC Switches encompasses a wide variety of products that have been determined safe and effective as over-the-counter products, once available only by prescription.
Aging baby boomers, many of which are taking greater interest in their health, have created a growing Rx-to-OTC industry in America. This was reinforced by the pandemic, which presented patients with more selfcare due to lockdowns and mandates. It is anticipated that Rx-to-OTC switch products will continue to grow as interest from both consumers and developers continue to expand. Many of the new products that are on the market may be potential candidates after standing the test of time as a prescription product. Also, the demand for OTC products is not likely to diminish, giving rise to more possibilities in the switched categories. Over one third of American consumers use an OTC medication at least every other day and the numbers are increasing on a regular basis as more products appear on the OTC market.
The current climate of patient-consumer awareness of health issues is continuing to influence the Rx-to-OTC market. Consumers are more prepared to take responsibility for their own health and are willing to purchase medicines over the counter. An increased focus on cost-savings, coupled with the effects of advertising and promotion, result in a higher rate of OTC purchases.
This report, The Market for Rx-to-OTC Switches, 8th Edition, analyses recent switches, products that are near switching. It estimates markets for switched products. Kalorama has examined this market in the past but this report reflects the most up-to-date analysis from Kalorama’s last report in 2017.
As part of its coverage, this report contains:
Issues and Trends Affecting The Rx-To-OTC Switches Market
Leading Participants
Information on the OTC industry
Overview Of The Over-The-Counter Drug Market
International Trends In Rx-To-OTC Switches
Markets by Category
Allergy, Cough, Cold, and Sinus Products: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
Analgesics and Other Pain Relievers Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
Anti-Infectives: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
Gastrointestinal Drugs: Recent Switches, Market Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents), Conditions Information, Overview
Other Drugs: Recent Switches, Overview, Size, Forecast, Market Share, Brand vs. Switched Brands vs. Generics (Switched Equivalents)
Total Market: Market Size, Forecast, Market Share
Company Coverage
There are several companies that compete heavily in this market and use the Rx-to-OTC switch as a major part of their life-cycle management arsenal. Companies involved in the Rx-to-OTC switched market include brand, generic, and private label manufacturers. Competition will likely continue to be intense in the OTC market.
Consolidation remains a major factor in this market. Most major players have made a significant acquisition or formed a strategic alliance to increase revenues and drive growth. Product innovation, line extensions and strong promotional support are a few of the top strategies for growth in this industry.
Leading competitors offering key brand products are provided in this report. These companies include:
Bayer
Glaxosmithkline
Johnson & Johnson
Perrigo Company
Prestige Brands
Procter & Gamble
Reckitt Benckiser
Sanofi (Chattem)
Products Discussed In This Report:
Carafate
Protonix
Zofran
Nicorette
Commit
Habitrol
Dimetapp
Dristan
Sudafed
Actifed
Benadryl
Drixoral Plus
Nyquil
Naphcon A
Nasalcrom
Mucinex
Claritin
Zyrtec
Aleve
Allegra
Astepro
Lastacaft
Aciphex
Dexilant
Zovirax
Xofluza
Maxalt
Zomig
Climara
Estraderm
Detrol
Retin-A
Lodine
Relafen
Zetia
Vytorin
TriCor
Proscar
Zithromax
Bactroban
Chantix
Lunesta
Ambien
Flomax
and Scores of Other Brands
The Food and Drug Administration (FDA) is the regulatory authority supervising both the prescription and over-the-counter drug approvals and Rx-to-OTC switches. Through a process, the FDA decides if Rx medications meet the requirements to become OTC available drugs if and when a petition is filed. The FDA evaluates a drug for OTC use upon several factors within a benefit-to-risk comparison. The evaluation includes:
Safety—potential overdose or poisoning with possible misuse of the drug and side effects of the drug is determined.
Compliance—understanding of OTC label information for proper dosing and administration and correct use without the direction of a physician or pharmacist.
Effectiveness—effective treatment of symptoms at doses appropriate for OTC use.
Follow up Care—correct diagnosis among consumers for common conditions and follow-up for unresolved symptoms.
Prescription drugs can be introduced for a switch evaluation in one of two ways, either by the manufacturers’ submission of additional information to the original drug application for OTC or by a petition by another source for the FDA to evaluate a drug for OTC use.
Submissions to the FDA by a manufacturer are the most common process for an Rx-to-OTC switch. The manufacturer provides information and evidence to support that the drug is safe for self-administration. The submission usually includes data from clinical studies and a preliminary OTC product label, displaying clear instructions for use.
The OTC drug review is a continual assessment of a product by a panel of non-government experts who review a prescription drug’s ingredients to determine whether it meets the guidelines for use as a safe drug under OTC marketing regulations. This is a more unconventional process for OTC switches as the manufacturer has not provided data for a formal review of the drug.
Pharmacists Generally Favor Self-Medication
Pharmacists are generally in favor of self-medication and actively promote OTC products. Switches do provide a way for pharmacists to increase profit margins and expand their role as a professional healthcare advisor. In recent surveys pharmacists estimate consumers go on to purchase the pharmacists recommended product at least 85% of the time. It is becoming increasingly important for the health industry to promote the pharmacist-consumer relationship as new OTCs reach the market. However, several barriers to successful relationships have been noted, including:
Workload—busy workloads may prevent noticing consumers struggling with product selections.
Compensation—lack of compensation for counseling, advice, and recommendations to consumers.
Workspace—lack of room to provide adequate consumer counseling.
Embarrassment—consumers may not approach pharmacists due to feeling of embarrassment.
The pharmacist’s role is becoming enhanced as new products hit the market and the “behind the counter” approach emerges. Pharmacists should be available to assist consumers with several aspects of OTC selection and use. Changes in the industry could enhance the pharmacist’s position and increase the level of consumer interaction with pharmacists. A typical counseling session should follow similarly to the figure below.
This report describes these processes and trends in detail, and provides a comprehensive view of the market in 2022.
The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, government databases, and medical and business journals. Person-to-person, email and telephone interviews were the primary method of gathering information. Over the past decade of Kalorama’s research into this market segment, more than 50 direct interviews have been conducted with industry officials, consultants, health providers, company representatives and government personnel. These sources are the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, business development managers, division managers, and product representatives.
All market data pertains to the U.S. market at the manufacturers’ level. The base year for data is 2021. Compound annual growth rates (CAGRs) are provided for the 2021-2026, for each industry segment covered.
Table of Contents
Chapter 1: Executive Summary
Overview
Scope and Methodology
Size and Growth of the Market
Table 1-1: The U.S. Market for Rx-to-OTC Switches, 2021-2026
Issues and Trends Affecting the Rx-to-OTC Switches Market
Leading Participants
Chapter 2: The OTC Drug Industry
Overview of the Over-the-Counter Drug Market
Distribution Channels
Table 2-1: Number of Retail Establishments in the United States and Non-Prescription Medicine Availability, 2017
Retail Market Value – OTC Drug Industry
Figure 2-1: U.S. OTC Retail Sales, 2000-2021
Development of the Rx-to-OTC Drug Market
Table 2-2: Rx-to-OTC Switches Approved by the FDA, 1976–2021
Figure 2-2: Number of New Rx-to-OTC Switches in the United States, per Year 1976-2021
Table 2-3: Estimated OTC Sales by Product Category and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients
Figure 2-3: Estimated OTC Sales by Product Type and Percent of Sales Attributed to Rx-to-OTC Switched Ingredients (% of total OTC Drug market)
U.S. Drug Regulation
Expanding Drug Access with Behind the Counter Status
Nonprescription Drug Safe Use Regulatory Expansion (NSURE)
Physician Uncertainty in Increasing Nonprescription Drug Access
Pharmacists Generally Favor Self-Medication
Figure 2-4: Typical Pharmacist-Consumer OTC Drug Counseling Session
Online Resources for Health Information and Drug Selection
Figure 2-5: Internet Uptake has Accelerated During the Pandemic According to the International Telecommunications Union, 2005-2021*
Social Media’s Influence on Consumer Health Products
U.S. Demographics and the Non-Prescription Drug Market
Figure 2-6: U.S. Population 2020 and 2030 – > 65 years and < 65 years
U.S. Health Spending Indicators
Table 2-4: U.S. Healthcare Industry Inflation Rates: Healthcare Industry Consumer Price Index Comparisons, 2015-2020 Data
International Trends in Rx-to-OTC Switches
Table 2-5: Legal Classification Status of Selected Ingredients by Country (Country Code, Alpha-2) (updated through March 2022)
Chapter 3: Allergy, Cough, Cold, and Sinus Products
Overview
Antihistamines
Decongestants
Cough Preparations
Ophthalmic Preparations
Other Allergy Preparations
Mast Cell Stabilizers
Intranasal Steroids
Description of Conditions
Allergic Rhinitis
Common Cold
Sinusitis
Hives
Ocular Allergies
Figure 3-1: Respiratory Symptoms Impacting Total U.S. Population, Average Annual
Product Analysis
Switched Products
Table 3-1: Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC Status
Figure 3-2: Allergy, Cough, Cold, Sinus Product Ingredients Transferred from Rx-to-OTC by Year
Recent Switch Activity
Astepro
Pataday Ophthalmic Spray and Solution
Lastacaft
Nasonex 24hr Allergy
Prescription Products with Anticipated OTC Approvals
