Market Overview

Teva Wins FDA Approval For Generic Epinephrine

Share:
Teva Wins FDA Approval For Generic Epinephrine
Related TEVA
Mid-Morning Market Update: Markets Mostly Lower; Teva's Preventive Migraine Treatment Approved By FDA
10 Biggest Price Target Changes For Monday
House nixes drug prices in TV ads (Seeking Alpha)
Related MYL
The Week Ahead In Biotech (Sept. 16-22): Conferences, PDUFA Dates, Clinical Trial Results And IPOs
The Daily Biotech Pulse: Aveo Slips On Stock Offering, FDA Greenlights Generic EpiPen, Pfenex Exec Resigns
Theravance Bio's revefenacin shows treatment effect in late-stage COPD studies (Seeking Alpha)

After nearly two years, the U.S. Food & Drug Administration has finally approved the generic versions of the EpiPen produced by Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA).

What Happened?

On Thursday, the FDA approved Teva's generic versions of the EpiPen and EpiPen Jr. epinephrine auto-injectors for patients with severe allergies.

“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb said in a statement.

Why It’s Important

For the first time in history, EpiPen producer Mylan NV (NASDAQ: MYL) will have a competitor in the market. Mylan introduced a generic alternative to its own EpiPen back in 2016.

Mylan has been criticized for hiking the price of its potentially life-saving EpiPen by more than 400 percent over a 10-year period. More competition in the market could potentially drive down the price for allergy sufferers who have difficulty affording the device.

Mylan’s EpiPen costs roughly $600, while its own generic alternative costs roughly half the price.

What’s Next?

Mylan stock traded down by only 0.3 percent on Thursday, but Teva shares surged 6.5 percent. Investors will be watching closely for details about the planned timing of Teva’s generic pens, exactly what its price point will be and how much market share the company could take from Mylan.

The potential exists for Teva’s generic EpiPen to significantly underprice Mylan’s generic version, as Mylan has had the market cornered until now. 

Related Links:

Q2 13F Roundup: How Buffett, Einhorn, Loeb And Others Adjusted Their Portfolio

Analyst: Opioid Legislation Likely Stalled In Senate Until After November Elections

Posted-In: EpiPenNews Health Care FDA Top Stories General Best of Benzinga

 

Related Articles (MYL + TEVA)

View Comments and Join the Discussion!

Earnings Scheduled For August 17, 2018

Jon Najarian Sees Unusual Options Activity In JD.Com And Dicks Sporting Goods