Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study

Rhea-AI Summary

Elite Pharmaceuticals (OTCQB: ELTP) reported positive results from a pivotal bioequivalence study for an undisclosed generic anticonvulsant on June 15, 2026. The study showed the generic is bioequivalent to the branded drug under fasting conditions. IQVIA reported combined branded and generic sales of $840 million for the twelve months ending April 2026. Elite is compiling data to file an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration.

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Positive

• Pivotal bioequivalence study showed generic anticonvulsant matches branded drug under fasting conditions
• Target market size cited at $840 million sales in twelve months ending April 2026
• Company preparing data package to file an ANDA with the US FDA

Negative

• None.

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Northvale, New Jersey--(Newsfile Corp. - June 15, 2026) - 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 anticonvulsant generic drug product.

IQVIA reported branded and generic product sales for the twelve months ending April 2026 of $840 million.

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/301416

FAQ

What did Elite Pharmaceuticals (OTCQB: ELTP) announce on June 15, 2026?

Elite Pharmaceuticals announced positive pivotal bioequivalence results for an undisclosed generic anticonvulsant. According to Elite, the study showed its product is bioequivalent to the branded drug under fasting conditions, supporting plans to submit an Abbreviated New Drug Application to the US Food and Drug Administration.

How large is the market for Elite Pharmaceuticals’ new generic anticonvulsant (ELTP)?

IQVIA reported that combined branded and generic anticonvulsant product sales reached $840 million for the twelve months ending April 2026. According to Elite, this sales figure represents the market their undisclosed generic anticonvulsant could target if approved following the planned Abbreviated New Drug Application filing.

What were the key design features of Elite Pharmaceuticals’ pivotal bioequivalence study?

The pivotal study was open-label, randomized, balanced, and single oral dose. According to Elite, it used a two-treatment, two-period, two-sequence, crossover design in normal, healthy adult human subjects under fasting conditions to assess bioequivalence between the generic anticonvulsant and its branded reference product.

What did the pivotal bioequivalence study results show for Elite Pharmaceuticals’ generic anticonvulsant?

The results indicated Elite’s generic anticonvulsant is bioequivalent to the branded reference drug. According to Elite, demonstrating bioequivalence under fasting conditions is a key requirement for supporting an Abbreviated New Drug Application submission to the US Food and Drug Administration for this product.

What are Elite Pharmaceuticals’ next steps after the positive bioequivalence study for ELTP?

Elite is compiling clinical and study data to support an Abbreviated New Drug Application. According to Elite, this ANDA will be filed with the US Food and Drug Administration for the undisclosed generic anticonvulsant, aiming to enter a market with $840 million in reported annual sales.

Was Elite Pharmaceuticals’ bioequivalence study for ELTP conducted under fasting or fed conditions?

The bioequivalence study was conducted under fasting conditions in healthy adult subjects. According to Elite, the open-label, randomized, crossover design compared a single oral dose of the generic anticonvulsant against its branded reference product to determine pharmacokinetic equivalence under these specific conditions.