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.  

Before 2020, the last branded switches approved were back in January 2017 for Xyzal Allergy 24HR (levocetirizine dihydrochloride) by Chattem and December 2017 for Lumify redness relief eye drops (briminodine tartrate) by Bausch & Lomb. In 2016, approved branded switches included Flonase Sensimist Allergy Relief (flucticasone furoate) by GlaxoSmithKline and Differin Gel for acne (adapalene) by Galderma Laboratories.  There were no switch approvals in 2018 or 2019. To better visualize the key switches that were approved over time, download our U.S. Rx-to-OTC Switch Progression infographic.

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

  Brand Company Active ingredient Dosage Type of  application Date of approval Date of launch Indications
 

 

 

 

Pataday Once Daily Relief

 

 

 

Alcon Laboratories

 

 

 

olopatadine

 

 

 

0.2%

 

 

 

sNDA

 

 

 

2/14/20

 

 

 

Mar. 20

 

 

 

Ocular antihistamine and redness reliever

 

 

 

 

Pataday Twice Daily Relief

 

 

 

Alcon Laboratories

 

 

 

olopatadine

 

 

 

0.1%

 

 

 

sNDA

 

 

 

2/14/20

 

 

 

Mar. 20

 

 

 

Ocular antihistamine and redness reliever

 

 

 

 

Pataday Once Daily Relief

 

 

 

Alcon Laboratories

 

 

 

olopatadine

 

 

 

0.7%

 

 

 

sNDA

 

 

 

7/13/20

 

 

 

Aug. 20

 

 

 

Ocular antihistamine and  allergic conjunctivitis

 

 

 

 

Voltaren Arthritis Pain Gel

 

 

 

GlaxoSmithKline

 

 

 

diclofenac

 

 

 

0.1%

 

 

 

sNDA

 

 

 

2/14/20

 

 

 

May 20

 

 

 

External analgesic for daily treatment of arthritis pain

 

 

 

 

Sklice

 

 

 

Arbor Pharmaceuticals

 

 

 

ivermectin

 

 

 

0.5%

 

 

 

sNDA

 

 

 

10/27/20

 

 

 

 

 

 

Shampoo for lice treatment

The market is poised for increased switch activity in existing and new OTC categories, as detailed in Kline’s upcoming Rx-to-OTC Switch Forecasts study.  Categories including allergy, BPH, ED, cholesterol, influenza, oral contraceptives, OAB, rescue products, sleeping aids, smoking cessation, and topical analgesics are analyzed. This study provides a comprehensive, objective assessment of the Rx-to-OTC switch landscape, including forecasts of switches in the United States in existing OTC categories and projections for new OTC categories.  

The study provides a broad assessment of “switchable” OTC categories, a specific analysis and forecasts for the most-likely switch categories and drugs, and an analysis of regulatory and retail paradigm shifts and implications for future switches. In addition to a detailed written report, this service provides Kline’s interactive and proprietary FutureView Forecasting Model to help users predict sales of new switches.  To learn more, contact us.   

 

 

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