Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study

Rhea-AI Summary

Elite Pharmaceuticals (OTCQB: ELTP) announced successful results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug. The study demonstrated bioequivalence to a branded product with annual sales of $27 billion (IQVIA, April 2025). The generic drug was tested in a randomized, balanced, single oral dose study under fasting conditions. The branded product currently has no generic competition and maintains unexpired patent protection. Elite plans to file an Abbreviated New Drug Application (ANDA) with the FDA, though commercialization depends on successful filing, FDA approval, and addressing patent issues.

Positive

• Successful bioequivalence study results for a potential generic anticoagulant drug
• Target branded drug has substantial market size of $27 billion in annual sales
• No current generic competition in the market
• Company advancing towards ANDA filing with the FDA

Negative

• Unexpired patent protection could delay or prevent market entry
• Commercialization faces multiple hurdles including FDA approval and patent challenges
• Specific details about the drug candidate remain undisclosed

Northvale, New Jersey--(Newsfile Corp. - June 16, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug product.

IQVIA reported branded product sales for the twelve months ending April 2025 of $27 billion. There is no generic product on the market, and the brand has an unexpired patent listed in the Orange Book. Commercialization of a generic product depends on successful filing, FDA approval and addressing the unexpired patent.

The studies conducted were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence studies in normal, healthy, adult, human subjects under fasting conditions. The results indicated that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.

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/255639

FAQ

What were the results of Elite Pharmaceuticals' (ELTP) bioequivalence study?

Elite Pharmaceuticals reported positive results, demonstrating that their generic anticoagulant drug is bioequivalent to the branded product in healthy adult subjects under fasting conditions.

What is the market size for the branded drug that Elite Pharmaceuticals is targeting?

According to IQVIA, the branded product had sales of $27 billion for the twelve months ending April 2025.

What are the main challenges for Elite Pharmaceuticals' generic drug commercialization?

The main challenges include successful FDA filing, obtaining FDA approval, and addressing the unexpired patent listed in the Orange Book.

What type of study did Elite Pharmaceuticals conduct for their generic anticoagulant?

Elite conducted open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence studies in healthy adult subjects under fasting conditions.

What is Elite Pharmaceuticals' next step after the successful bioequivalence study?

Elite is compiling the data to file an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration.