PRI claims exclusivity for generic Prozac

18 January 2001

Pharmaceutical Resources Inc believes it will have exclusive rights tomarket a generic version of Eli Lilly's Prozac (fluoxetine) tablets in the USA for 180 days after approval on the basis of the first-to-file rule. The company has a strategic alliance with Merck KGaA giving it rights to market a generic form of the antidepressant, filed by Merck subsidiary Alphapharm in the USA.

While tablet sales of Prozac in the USA are around $65 million a year, PRI believes its fluoxetine range should be able to compete with the $2 billion of branded capsule sales prescribed in similar dosage strengths. The timing of the market launch of the product depends upon the outcome of litigation between Lilly and Alphapharm and Food and Drug Administration approval, but PRI is optimistic it may be able to launch the generic sometime between August 2001 and September 2002.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >

Today's issue

Company Spotlight

Ironwood is a US-based biotech advancing a pipeline of medicines in multiple areas of significant unmet need, including irritable bowel syndrome with constipation ((IBS-C)/chronic idiopathic constipation (CIC), vascular and fibrotic diseases, and refractory gastroesophageal reflux disease, among others.