1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Regulation

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

More from Policy & Regulation

Innovations In US Hemp Market, Like States’ Regulatory Interest, More Than Skin Deep

 
• By Malcolm Spicer

Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.