UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 December 23, 2003 ----------------- (Date of Report) ELITE PHARMACEUTICALS, INC. ------------------------------------------------------ (Exact name of registrant as specified in its charter) Delaware 333-45241 22-3542636 ---------------------------- ------------ ------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 165 Ludlow Avenue, Northvale, New Jersey 07647 ---------------------------------------------- (Address of principal executive offices) (201) 750-2646 ---------------------------------------------------- (Registrant's telephone number, including area code) Item 5. Other Events and Regulation FD Disclosure ----------------------------------------- Registrant issued on December 23, 2003 a press release announcing its agreement with Pivotal Development, LLC to develop a controlled release product utilizing Elite's proprietary drug delivery technology. A copy of Registrant's press release is attached as Exhibit 99.1. Item 7. Financial Statements and Exhibits --------------------------------- a) Not applicable. b) Not applicable. c) Exhibits 99.1. Press Release, dated December 23, 2003 2 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: December 23, 2003 ELITE PHARMACEUTICALS, INC. By: /s/ BERNARD BERK ------------------------------ Name: Bernard Berk Title: Chief Executive Officer 3