Please login to the form below

Not currently logged in
Email:
Password:

FDA approval for OTC delayed release omeprazole in US

The FDA grants final approval to Perrigo and its partner Dexcel Pharma Technologies to sell 20 mg omeprazole delayed-release tablets in the US

Over-the-counter (OTC) drug manufacturer and marketer Perrigo has said that the FDA has granted final approval to its partner Dexcel Pharma Technologies to sell 20 mg omeprazole delayed-release tablets in the US.

As the exclusive marketer and distributor of this product for the store brand OTC market in the US, Perrigo expects to begin shipping its product during Q1 2008. The company says its full year annual sales could be in the region of USD 150m to USD 200m.

Omeprazole is the active ingredient in UK-headquartered AstraZeneca's now off-patent antacid blockbuster Prilosec. Prilosec OTC is indicated for the treatment of frequent heartburn and had estimated current annual sales of approximately USD 750m in all US outlets, says Perrigo.

Based on pre-launch estimates, Perrigo's Omeprazole product is expected to contribute between USD 0.20 and USD 0.25 earnings per share in FY08. As a result of the Omeprazole launch, FY08 earnings are expected to be in the range of USD 1.32 to USD 1.47 per share.

Omeprazole is also sold OTC in a non-delayed release form by Proctor & Gamble.

11th December 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
CMR

Specialising in medical device market research, our approach is people-centric and we thrive on making connections with clients and research...

Latest intelligence

ABPI2018
The NHS and ABPI at 70: inching closer to the triple win
The NHS and UK pharma’s ABPI both turn 70 this year. After years of transactional relationships, there’s a will to work more closely - but friction on prices and value...
What pharma marketers can learn from behavioural science
Pharma behavioural science and traditional emotional marketing create a powerful mix of techniques that have impact on real lives....
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE The bold digital clock featured on the EUGDPR (EU General Data Protection Regulation)1 website indicates – to the second...

Infographics