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Elite Pharmaceuticals Announces Commercial Launch of Oxycodone and Acetaminophen Tablets

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Elite Pharmaceuticals has announced the commercial launch of its generic version of Percocet (oxycodone hydrochloride and acetaminophen tablets, USP CII) in three different strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

The medication is specifically indicated for the treatment of moderate to moderately severe pain. This strategic product launch targets a significant market opportunity, as IQVIA reported annual sales of approximately $317 million for this product in 2024.

As a specialty pharmaceutical company focused on developing niche generic products, Elite's entry into this market represents a significant milestone in their product portfolio expansion. The company trades on the OTCQB market under the symbol ELTP.

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Positive

  • Commercial launch of generic Percocet across three dosage strengths
  • Entering market worth $317M in annual sales (2024 IQVIA data)
  • Expanding product portfolio in pain management segment

Negative

  • Entering highly competitive generic market with potential price pressure
  • Operating in regulated opioid market with associated risks

News Market Reaction – ELTP

+2.76%
1 alert
+2.76% News Effect

On the day this news was published, ELTP gained 2.76%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Northvale, New Jersey--(Newsfile Corp. - April 30, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that the company has launched Elite's generic version of Percocet® (oxycodone hydrochloride and acetaminophen tablets, USP CII) 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Oxycodone HCl and acetaminophen is indicated for the relief of moderate to moderately severe pain.

IQVIA reported 2024 annual sales of approximately $317 million 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 www.elitepharma.com.

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.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/250318

FAQ

What new generic drug did Elite Pharmaceuticals (ELTP) launch in April 2025?

Elite Pharmaceuticals launched a generic version of Percocet (oxycodone hydrochloride and acetaminophen tablets) in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

How big is the market for Elite Pharmaceuticals' new oxycodone and acetaminophen tablets?

According to IQVIA data, the annual sales for this product were approximately $317 million in 2024.

What medical conditions will Elite Pharmaceuticals' new generic Percocet treat?

The oxycodone HCl and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

What strengths of generic Percocet is Elite Pharmaceuticals (ELTP) offering?

Elite Pharmaceuticals is offering their generic Percocet in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg tablets.

When did Elite Pharmaceuticals (ELTP) begin commercial sales of generic Percocet?

Elite Pharmaceuticals launched their generic version of Percocet commercially on April 30, 2025.
Elite Pharmaceuticals Inc

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Drug Manufacturers - Specialty & Generic
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United States
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