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Market Exclusivity Decision Pending For Bayer’s First-In-Class OTC Switch Astepro Allergy

 
• By Malcolm Spicer

Astepro Allergy’s attributes include being the first steroid-free, antihistamine nasal spray for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief. An attribute yet to be determined will have most influence on revenue boost for Bayer: three-year market exclusivity.

Astepro Allergy labeling was approved with Bayer's NDA for an OTC switch of azelastine hydrochloride nasal spray. • Source: FDA

It’s clear that Bayer AG has a first-in-class OTC allergy product it plans to launch in the US in 2022. What’s not clear is whether Astepro Allergy’s boost to the firm’s consumer health business sales will be enhanced by market exclusivity.

The German firm’s Bayer Healthcare LLC business in Whippany, NJ, has labeling approved for eight separate packaging configurations of the azelastine hydrochloride nasal spray, 205

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