NEPTUNE, N.J., Jan. 31 /PRNewswire/ -- WellSpring Pharmaceutical Corporation announced today that it has received FDA clearance to market its 50mg strength of bethanechol chloride in the US. Duvoid(R) is indicated for the management of disorders of the urinary tract and bladder. Duvoid(R) will be positioned as a generic alternative to Urecholine(R) (Pliva). Sales of Urecholine(R) during the past 12 months were approximately $50 million.
The 50mg tablet strength will be manufactured by WellSpring's FDA- approved, Oakville, Ontario, manufacturing plant near Toronto, as are the 10mg and 25mg strengths. Because Duvoid(R) is being manufactured in Canada, an approved trading partner with the United States, certain Veterans Administration purchases will be permitted for this brand of bethanechol to the exclusion of suppliers who originate inventory in India.
WellSpring has indicated that it intends to market Duvoid(R) through a licensing arrangement with a third party. WellSpring is also considering the development of new dosage forms and new indications for Duvoid(R), which will require the submission of new applications to the FDA. Any new indication for bethanechol chloride will receive a period of market exclusivity as granted by the Waxman-Hatch Act. This would mean that substitution of Duvoid(R) by other generic forms would not be permitted for those new indications.
WellSpring Pharmaceutical Corporation's Founder and CEO, Dr. Robert A. Vukovich, commented on the new agreement: "The strategic focus of WellSpring is on the development of new and novel prescription drug products. Our decision to develop and sell this branded generic form of bethanechol will provide us with additional financial resources with which to continue the development of line extensions and new indications for the drug."
Contact: Pat Naffin
Tel: (732) 938-5885
Fax: (732) 751-9056
WellSpring is a privately held pharmaceutical company founded in 1999 by Dr. Robert A. Vukovich, the firm's CEO and Chairman. Dr. Vukovich previously founded and managed Roberts Pharmaceutical Corporation of Eatontown, NJ, until its acquisition by Shire Pharmaceutical Group, in 1999. WellSpring manufactures and sells Dyrenium(R), a potassium-sparing diuretic used to manage congestive heart failure and the edema associated with certain liver diseases. The firm also markets Dibenzyline(R), a non-selective non- reversible alpha-receptor blocker approved for the control of severe hypertension associated with certain cancers. The firm is developing a late stage drug, Stanate(R), for the treatment of neonatal jaundice. US rights to Stanate(R) were licensed to a sister company, InfaCare Pharmaceutical Corporation. WellSpring is located in Neptune, NJ.
WellSpring Pharmaceutical Corporation