Elite Pharmaceuticals, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsElite Pharmaceuticals is a specialty generic drug manufacturer focused on controlled-release oral products, with a growing portfolio sold under its own Elite Laboratories label.
What they do
Elite Pharmaceuticals develops, manufactures, and distributes generic oral controlled-release and immediate-release pharmaceuticals, operating a cGMP and DEA-registered facility in Northvale, NJ. The company generates revenue from manufacturing fees and licensing fees, and sells products under its own Elite Laboratories label as well as through third-party manufacturing agreements.
Revenue drivers
- Manufacturing fees — $147.8 million in FY2026 (fiscal year ended March 31, 2026), up 80% from $82.0 million, driven by launches such as Oxy APAP tablets, Lisdex capsules, and Naltrexone and Phentermine tablets.
- Elite label product sales — Sales of products under the Elite Labs label, including Naltrexone and Phentermine tablets, began during the last half of FY2026 and are a key growth area.
- New product launches — Recent launches include generic methadone HCl tablets (April 2026) and Ropinirole ER tablets (August 2026), contributing to revenue growth.
- Licensing fees — $1.1 million in FY2026, down 48% as the company transitions away from licensing to third parties toward marketing its own label.
Recent performance
For Q1 FY2027 (quarter ended June 30, 2026), revenue was $32.4 million, down 19.5% from the prior year quarter, which had the highest quarterly revenue in company history. Income from operations was $7.5 million, down 65% due to lower margins on the generic Vyvanse product line amid competitive market adjustments. Net income attributable to common shareholders was $5.9 million. FY2026 revenue was $148.9 million with net income of $44.9 million, versus $84.0 million and a net loss of $4.3 million in FY2025.
Strategy
The company focuses on developing generic versions of controlled-release drugs with high barriers to entry, diversifying its product portfolio, and expanding sales under its own Elite Laboratories label. It continues to evaluate both branded and generic product opportunities, including co-development projects and licensing agreements. Management is investing in new product development, as seen by an ANDA filed in June 2026 for a generic anticoagulant and a pivotal bioequivalence study for an anticonvulsant.
Risks
- Competitive pricing pressure — The generic Vyvanse product line experienced lower margins due to competitive market adjustments, impacting Q1 FY2027 results.
- Dependence on sole facility — Operations are concentrated at the Northvale, NJ facility; interruptions there could have a material adverse effect on the business.
- Regulatory and legal risks — The company faces patent litigation, as seen in the Purdue Pharma suit dismissed in June 2026, and delays in FDA approvals could affect product launches.
- Product concentration — Revenue is highly dependent on a limited number of products, including Lisdex and Oxy APAP, and the introduction of generic equivalents could reduce sales.
Outlook
Management expects Q1 FY2027 results to be in line with the three prior quarters, suggesting a more stable run rate after the competitive adjustment. The company is expanding its product portfolio with recent launches and pipeline developments, including an anticoagulant ANDA and positive bioequivalence results for an anticonvulsant. Future growth is anticipated from increased Elite label sales and new product approvals.