Recent Rx-to-OTC Switches in the U.S.

Five Newly Approved Switches Hit the U.S. Market

The U.S. FDA approved five new branded Rx-to-OTC switches in 2020, including eye drops, an external analgesic, and a lice treatment. In additionprivate-label companies such as Perrigo and Mylan gained approval for store brand versions of Voltaren Arthritis Pain Gel, Prevacid 24HR proton pump inhibitor, and Nicorette smoking cessation gum this year. These approvals come after a lull in switch activity during the past two years.  Continue reading

Nonprescription Drugs USA

Solid Growth in Most Markets and New Switches Propel the U.S. OTC Market

Driven by the solid growth of most markets, sales of the U.S. OTC market increase by 3% in 2015. Particularly high gains are seen in the allergy and antacids markets, fueled by recent Rx-to-OTC switch brands, such as Flonase Allergy Relief by GlaxoSmithKline and Nexium 24HR by Pfizer. Recently released sales data from our annual Nonprescription Drugs USA market study pegs the upper respiratory market at more than 7% growth and digestive products at almost 5% from 2014 to 2015. These growth rates are well above the average growth for these markets, propelled by new switch brands being launched and bringing in previous users of these medications from the prescription market to the OTC market.Continue reading

Pfizer/Allergan Deal

Merger and Tax Inversion are Distractions from the Crux of the Pfizer/Allergan Deal

On Monday, November 23, 2015, while many were working a short work week due to the Thanksgiving holiday in the United States, Pfizer and Allergan management were busy announcing a merger that will create the world’s largest pharmaceutical company valued at $160 billion. On the surface, analysts and politicians focused on the tax inversion created by this deal because Allergan (the smaller of the two companies) is acquiring the larger Pfizer. The reason is that Allergan (formerly of Irvine, CA) is headquartered in Dublin, Ireland, where corporate tax rates are lower than they are in the United States, where Pfizer is based. Once approved, this will mean corporate taxes for the new company (to be called Pfizer) will drop from a rate of 25% to 17%-18%.

The deal with Allergan comes after Pfizer attempted a hostile takeover of rival pharmaceutical company, AstraZeneca, based in London, England, in 2014, which was refused by AstraZeneca and frowned upon by British regulators. Tax inversion is not a new phenomenon, and the re-domiciling of corporate headquarters to places like Bermuda and Ireland have happened in many industries, not just in pharmaceuticals.Continue reading

Nonprescription Drugs USA

Top Three Drivers of the U.S. OTC Market

Estimated at over $24 billion at the manufacturers’ level in 2014, the U.S. nonprescription drugs market shows interesting opportunities for its players, posting growth in five out of the seven product classes tracked in Kline’s annual Nonprescription Drugs USA report. Let’s take a look at the top three drivers behind this market’s success:

  1. Rx-to-OTC switches – the big game changer

Rx-to-OTC switches represent the core driver of market growth as they involve large, popular brands, bringing former prescription users to the OTC market. According to our recently released Rx-to-OTC Switch Pipelines USA: Competitive Assessment, the increasingly favorable regulatory environment facilitated the approval of four new and important switches, in categories that five years ago would have been considered as challenging.Continue reading

Nonprescription Drugs USA

Another Prosperous Year for the Nonprescription Drugs Industry

Recently released data from our Nonprescription Drugs USA study shows that the U.S. nonprescription drugs industry posted moderate growth in 2014, recording revenue growth for the sixth consecutive year. Estimated at $24+ billion at the manufacturers’ level, the market climbs by 1.4% from 2013 to 2014. Out of the seven product classes we track, five posted growth, with upper respiratory, digestive products, and feminine products moving at a faster pace.

Among the key factors supporting the market’s growth are the sales and shares increases from select switch brands, such as Pfizer’s Nexium 24HR, which drove solid growth in the digestive products category, as well as the launch of Sanofi’s Nasacort 24HR, which generated healthy gains in the allergy category.Continue reading

Rx-to-OTC Switch

Broader Opportunities in Rx-to-OTC Switch

There have been signs recently indicating that the environment is becoming ripe for more Rx-to-OTC switches. Since we last reported on this topic in August 2013, we saw the approval of two additional first-in-class switches in categories that would have been thought of as challenging five years ago. One is the first incontinence medication available for sale without a prescription, Merck’s Oxytrol for Women, and the other is the first nasal allergy steroid, Sanofi’s Nasacort Allergy 24HR.Continue reading

U.S. OTC Market Posts Solid Growth in 2011 Driven by Rx-to-OTC Switches and Marketing

U.S. OTC Market Posts Solid Growth in 2011 Driven by Rx-to-OTC Switches and Marketing

From 2010 to 2011, the U.S. OTC drug market posted a gain of 2.4% from $20.9 billion in 2010 to $21.4 billion in 2011 at the manufacturers’ level. The fastest growing categories include allergy relief products, which grew 16.3% in 2011 aided by the market launch of Rx-to-OTC switch brand Allegra (Sanofi-Aventis) and the strong growth of private-label allergy relief products. Past Rx-to-OTC switch brands continue to perform well with Rogaine (Johnson & Johnson) and Plan B (Teva Pharmaceutical), both posting strong gains in the hair regrowth products and contraceptives markets, respectively.

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