SPRING VALLEY, N.Y., July 8 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that Xcel Pharmaceuticals, Inc. has filed suit against Par's subsidiary, Kali Laboratories Inc., regarding Kali's filing of an Abbreviated New Drug Application (ANDA) for diazepam rectal gel, the generic version of Diastat(R). Xcel sued Kali for patent infringement in United States District Court for the District of New Jersey. Par believes that Kali is the first-to-file an ANDA with a paragraph IV certification for diazepam rectal gel and may be entitled to up to 180 days of marketing exclusivity for the product.
Diastat(R) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Diastat(R) has annual U.S. sales of approximately $50 million.
Par has built a new product pipeline that includes more than 60 drugs in active development and 38 ANDAs filed with the U.S. Food and Drug Administration (FDA), and awaiting approval. Among these 38 drugs, Par believes as many as eight may represent first-to-file opportunities entitling the company, or its partner, up to 180 days of marketing exclusivity, or co- exclusivity. It should be noted that it is difficult to know with certainty that an ANDA filing has exclusivity, or shared exclusivity, until final approval is received from the FDA. Par submitted its first New Drug Application in June for an advanced formulation of the company's currently marketed megestrol acetate oral suspension product. The new product, if approved, will utilize the Megace(R) brand name, which Par licensed from Bristol-Myers Squibb Company.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Through its FineTech subsidiary, Par also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. Par currently manufactures, markets or licenses 80 prescription drugs. For press release and other company information, visit http://www.parpharm.com/.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.