Please ensure Javascript is enabled for purposes of website accessibility

Teva Pharmaceutical Gets a Taste of Its Own Medicine As the FDA Approves a Generic of Its Asthma Drug

By Brian Orelli, PhD - Feb 24, 2020 at 8:08PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

A generic approval for Perrigo of Teva's ProAir HFA was highly anticipated.

Teva Pharmaceutical (TEVA 0.29%), which is known for its generic-drug business but has some branded drugs as well, is getting a taste of its own medicine as the Food and Drug Administration approved a generic version of its asthma drug ProAir HFA, which was developed by Perrigo (PRGO -0.97%).

ProAir HFA is one of the most commonly used rescue inhalers in the U.S., with North America sales up 77% year over year to $80 million in the fourth quarter of last year, although the increase was due to higher sales reserves recorded in anticipation of generic competition. For the year, sales of the branded drug were down 31% as Teva launched an authorized generic of the drug in January 2019.

Patient using an inhaler

Image source: Getty Images.

Inhalers tend to be hard to copy because they require duplication of both the active substance, which is needed for all generic drugs, and the delivery device. For example, Advair, an asthma drug from GlaxoSmithKline (GSK -0.56%), was able to get a few years of extra exclusivity because generic-drug makers weren't able to meet the FDA's requirements until Mylan achieved the goal last year.

Through the Generic Drug User Fee Amendments, the FDA has pledged to support the development of complex generic-drug products such as inhalers. The agency is also committed to adjusting its focus on approvals from first-in-first-out to drugs, such as ProAir HFA, that don't have any generic competition. In fact, the office of generic drugs gives priority to applications up to the third generic drug because that's where the largest price drop occurs.

Brian Orelli and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Perrigo Company plc Stock Quote
Perrigo Company plc
$40.62 (-0.97%) $0.40
Teva Pharmaceutical Industries Limited Stock Quote
Teva Pharmaceutical Industries Limited
$10.37 (0.29%) $0.03
GSK Stock Quote
$34.06 (-0.56%) $0.19

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/19/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.