Elite Pharmaceuticals Files ANDA with US FDA to Market Opiate Analgesic Product

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Elite Pharmaceuticals files ANDA for generic drug product, FDA accepts for review
  • Elite Pharmaceuticals has filed an ANDA for an undisclosed generic drug product, and the application has been accepted for review by the FDA. This could potentially lead to the company's entry into the lucrative market of opiate analgesics. The brand and generic market for this product reported annual sales of $720 million for the twelve months ending June 2023, indicating significant revenue potential for Elite Pharmaceuticals.
  • None.

NORTHVALE, NJ / ACCESSWIRE / September 25, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company")(OTCQB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced that it filed an Abbreviated New Drug Application (ANDA) on August 17, 2023, and was accepted for review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations

SOURCE: Elite Pharmaceuticals, Inc.

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Pharmaceuticals: Generic, Health Technology, Manufacturing, Pharmaceutical Preparation Manufacturing

About ELTP

elite pharmaceuticals, inc. develops oral sustained and controlled release products. elite's strategy includes assisting partner companies in the life cycle management of products, to improve off-patent drug products, and developing generic versions of controlled release drug products with high barriers to entry. elite has four anda products partnered with tagi pharma; one anda has launched, two andas are in the process of a manufacturing site transfer and an additional anda is currently under review by the fda. elite also manufactures lodrane d® and receives royalties for lodrane d®, an allergy product partnered with ecr pharmaceuticals (“ecr”), a wholly owned subsidiary of hi-tech pharmacal (“hi-tech”). elite’s lead pipeline products, eli-216, a once-daily abuse resistant oxycodone, and eli-154, a once-daily oxycodone, are novel sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provisio