IMPAX Laboratories Inc has signed a series of agreements with Leiner Health Products, LLC for the supply and distribution of the Company's Loratadine Orally Disintegrating Tablets (ODT) and Loratadine and Pseudoephedrine Sulfate extended release tablets 24-hour products, according to a release.
Both of these products are indicated for the relief of symptoms of seasonal allergic rhinitis (hay fever). These products will be manufactured by IMPAX and marketed by Leiner as over the counter (OTC) store brand equivalents to both Claritin Reditabs and Claritin-D 24-hour respectively.
"These agreements with Leiner enable IMPAX to further capitalize on our Loratadine product portfolio," stated IMPAX's CEO Barry R. Edwards. "Leiner's strong position in the OTC store brand space should provide us with additional market presence," Edwards continued.
These new agreements are in addition to those previously announced with several major pharmaceutical companies for IMPAX's Loratadine product family.
IMPAX currently has 14 applications pending at the FDA, including five tentatively approved, which address approximately $5.2 billion in US product sales for the twelve months ended March 31, 2004, based on NDC Health data. Twelve of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
Claritin Reditabs and Claritin-D 24-hour are registered trademarks of Schering-Plough Corporation.