BD jumps into sterile injectables market, as Mylan, Teva expand

The generic sterile injectables business is filling up, if not getting a tiny bit crowded, as yet another player wades into a market that offers lots of opportunities for companies with new plants and new approaches. 

The medical technology company Becton Dickinson ($BDX) has gotten FDA approval for its first sterile injectable drug, the antihistamine Diphenhydramine Hydrochloride Injection, USP, it reported today. It will be manufactured by its BD RX subsidiary at a plant in North Carolina. And that is just the beginning. BD says it plans to roll out 20 to 30 more drugs over the next several years. Its angle is to charge a premium by selling them in the company's pre-filled syringe products, which it says are safer and save time.

BD is targeting a part of the business that has gotten lots of attention lately. The sterile injectables market is growing worldwide, even as some of the established players like Hospira ($HSP) and Boehringer Ingelheim's Ben Venue Laboratories are struggling with manufacturing issues and FDA approvals in the U.S. That has opened up lucrative opportunities for players like Hikma, the Jordan-based company, and Germany's Fresenius Kabi, which have both been cleaning up. As The Wall Street Journal reports, Hikma has expanded capacity and plans to bring to market 5 to 10 injectable drugs a year for the next 5 years. The new-found enchantment with injectables also means patients can expect more supply of some drugs that have lingered on the FDA shortages list.

Like BD, Hikma is looking at ways to stand out in a market noted for thin margins, WSJ reports. It got approval last year for argatroban, a blood thinner for people who are allergic to heparin. It reportedly sells for as much as $2,300 a vial. "We're trying to bring new, slightly more differentiated products to the market, and that's where we see the opportunity," Hikma's VP of corporate relations Susan Ringdal tells the newspaper. 

Bigger players also are waking up to the potential. Generic drugmaker Mylan ($MYL) was so taken with the upside of injectables that it agreed to pay $1.6 billion for India's Agila Specialties, which has modern and extensive injectables manufacturing. Teva Pharmaceutical Laboratories ($TEVA) has expanded it injectables capacity at a plant in Hungary, and Hospira bought a modern API plant in India to feed its operations.

- here's the BD release
- read FierceMedicalDevices' take
- get more from The Wall Street Journal (sub. req.)