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Elite Pharmaceuticals Gains FDA Approval for Generic Drug

Story Highlights
  • Elite Pharmaceuticals received FDA approval for a generic Parkinson’s drug.
  • The approval may enhance Elite’s market presence in niche generics, with $10 million U.S. sales noted.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Elite Pharmaceuticals Gains FDA Approval for Generic Drug

Meet Your ETF AI Analyst

Elite Pharmaceuticals ( (ELTP) ) just unveiled an update.

On November 12, 2025, Elite Pharmaceuticals announced it received FDA approval for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), used to treat Parkinson’s disease symptoms. This approval allows Elite to market the product under its Elite Laboratories label, potentially impacting the company’s market presence in the niche generic pharmaceutical sector, with the branded product and its equivalents having U.S. sales of $10 million for the twelve months ending September 2025.

The most recent analyst rating on (ELTP) stock is a Hold with a $0.50 price target. To see the full list of analyst forecasts on Elite Pharmaceuticals stock, see the ELTP Stock Forecast page.

Spark’s Take on ELTP Stock

According to Spark, TipRanks’ AI Analyst, ELTP is a Neutral.

The overall stock score is primarily impacted by financial performance and valuation concerns. While revenue growth is strong, profitability issues and cash flow inconsistencies pose significant risks. Technical analysis indicates mixed signals, with no clear trend, and valuation metrics are unattractive due to negative earnings and lack of dividends.

To see Spark’s full report on ELTP stock, click here.

More about Elite Pharmaceuticals

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. The company offers immediate-release and controlled-release solid oral dose products, marketed under the Elite Laboratories label and through licenses to third-party organizations. Elite operates a cGMP and DEA registered facility in Northvale, NJ.

Average Trading Volume: 1,219,993

Technical Sentiment Signal: Strong Buy

Current Market Cap: $678.2M

See more data about ELTP stock on TipRanks’ Stock Analysis page.

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