KV Gets Approval For Two Strengths Of Generic Versions Of Toprol-XL

Armen Hareyan's picture

KV Pharmaceutical Company has received final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application to market its 100 mg and 200 mg strengths of metoprolol succinate extended-release tablets.

This product is a generic version of AstraZeneca's branded product, Toprol-XL. Based on the Company's first-to-file status on its ANDA for these two strengths, KV anticipates being accorded the benefit of a 180- day generic exclusivity period for the marketing of these two dosage strengths. The Company expects to begin shipping in the near future. Additionally, the approval positions KV to eventually offer all four dosage strengths of generic metoprolol succinate extended release tablets pending receipt of FDA approval of its ANDA's for the remaining two strengths (25 mg and 50 mg).

Metoprolol succinate extended release tablets are indicated for the treatment of hypertension used alone or in combination with other antihypertensive agents, for the long-term treatment of angina pectoris and for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. Based on reports by third parties, sales of Toprol-XL in the U.S. in 2006 were $1.71 billion. In the 12-month period ended March 2007, total branded dollar volume of Toprol-XL for the 100 mg and 200 mg strengths was $779.2 million, according to IMS America.

Marc S. Hermelin, Vice Chairman and Chief Executive Officer of KV Pharmaceutical stated, "Today marks the most significant generic approval in the history of our ETHEX Corporation generic/non-branded subsidiary and serves as a strong validation of our ANDA filing strategy. Our expected six-month exclusivity on the 100mg and 200mg strengths should afford ETHEX a significant opportunity to substantially build its revenues and bottom line, and we will look to build this product line further upon approval of our ANDA's for the 25 mg and 50 mg dosage strengths.

"While this approval is clearly a key milestone for ETHEX and more broadly for all of KV, it is not the only important one we foresee in the months ahead. Additional catalysts for growth include:

-- Approval and Launch of EvaMist(TM) by our Ther-Rx branded business during the second half of fiscal 2008


-- Introduction of 4 to 6 additional new products throughout fiscal 2008

-- Anticipated filing with the U.S. Food and Drug Administration of the first generic products from the Company's collaboration agreement with Strides Arcolab

-- Approval from the U.S. Food and Drug Administration and launch of the first generic product under the Company's collaboration agreement with Gedeon Richter

We believe that these anticipated events position both our generic and branded businesses for outstanding growth opportunities in fiscal 2008 and beyond."

As previously reported, KV's ANDA filings for metoprolol succinate extended-release tablets were the subject of patent infringement litigation filed by the brand manufacturer AstraZeneca against KV and two co-defendants. In January 2006, the U.S. District Court for the Eastern District of Missouri granted the motion by KV and its co-defendants for summary judgment of the invalidity and unenforceability of both patents that were asserted by AstraZeneca (U.S. Patents 5,001,161 and 5,081,154).

Both patents were held invalid, as well as being held unenforceable for inequitable conduct committed by AstraZeneca during prosecution of the patents before the U.S. Patent and Trademark Office. AstraZeneca has appealed this decision to the U.S. Court of Appeals for the Federal Circuit, where a decision on the appeal is pending.

Toprol-XL is a registered trademark of the AstraZeneca group of companies.