According to our CHC New Products Tracker tool, which covers 20 key markets globally, 2020 was a relatively good year for Rx-to-OTC switch activity, not quite at the level of particularly active years like 2018, but above average in terms of switch-related launch developments, and with some notable breakthroughs such as GSK’s switch of Voltaren Arthritis Pain (diclofenac) in the USA and Glenmark’s Momate Rhino Advance Nasal Spray (mometasone + azelastine) switch in Russia.
Thanks to the Rx-to-OTC reclassification of Voltaren Arthritis Pain, as well as eye allergy itch relief range Pataday (Alcon), the US market led the way in terms of switch developments in 2020, along with Poland, Germany and China. As for category switch trends, looking at Tracker data for the past 8 years (2013 to 2020), allergy remedies has been by far the most active OTC subcategory in producing new products following switch activity, with double the amount of NPD activity as the next nearest subcategory, cough remedies.
Looking ahead to 2021, one of the first switch developments this year will again be an allergy remedy. The UK’s Medicines & Healthcare products Regulatory Agency granted GSL status to Sanofi’s Allevia tablets for seasonal allergic rhinitis (fexofenadine 120mg; 12+ years; 1 tablet per day) in late December 2020. Once Allevia and other OTC fexofenadine products are launched, they will enjoy mass market distribution from the outset (it is more common in the UK for switched ingredients to be granted pharmacy-only OTC status). This is the second Rx-to-GSL UK allergy remedy switch in as many months, following approval for J&J’s Rhinocort Aqua budesonide 64mcg nasal spray in November 2020 (to be marketed as Benacort Hayfever Relief).
In addition, Poland remains at the forefront of global switch activity, with the country’s medicines agency (URPL) recently approving the Rx-to-OTC switch of Famotydyna Ranigast film-coated tablets (Polpharma; famotidine 20mg). Claimed to relieve indigestion, heartburn and hyperacidity for up to 12 hours, this is the first famotidine option available OTC in Poland. Meanwhile, Australia’s TGA is seeking comments until 27th January 2021 on proposed amendments to the Poisons Standard, which will be discussed at the March 2021 meeting of the Advisory Committee on Medicines Scheduling, including adding the following pharmacist-only medicines to Appendix H to permit consumer advertising: prochlorperazine and metoclopramide for the treatment of nausea associated with migraine; and chloramphenicol for ophthalmic use.
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