Elite Pharmaceuticals Inc
OTC:ELTP
Elite Pharmaceuticals Inc
Elite Pharmaceuticals, Inc. engages in the development and manufacture of pharmacological abuse-deterrent opioid products. The company is headquartered in Northvale, New Jersey and currently employs 43 full-time employees. The company went IPO on 2014-02-20. The firm is principally engaged in the development and manufacture of oral, controlled-release products. The firm develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets (either on its own or by license to other companies) generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA) for generic products and New Drug Applications (NDA) for branded products. Elite owns, licenses and contract manufactures products, including Phentermine HCl 37.5mg tablets , Phendimetrazine Tartrate 35mg tablets, Naltrexone HCl 50mg tablets, Isradipine 2.5mg and 5mg capsules, Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets, Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules, among others.
Elite Pharmaceuticals, Inc. engages in the development and manufacture of pharmacological abuse-deterrent opioid products. The company is headquartered in Northvale, New Jersey and currently employs 43 full-time employees. The company went IPO on 2014-02-20. The firm is principally engaged in the development and manufacture of oral, controlled-release products. The firm develops and manufactures generic products, products using controlled-release drug technology, products utilizing abuse deterrent technologies, and it develops and markets (either on its own or by license to other companies) generic controlled-release and abuse deterrent pharmaceutical products. Its segments include Abbreviated New Drug Applications (ANDA) for generic products and New Drug Applications (NDA) for branded products. Elite owns, licenses and contract manufactures products, including Phentermine HCl 37.5mg tablets , Phendimetrazine Tartrate 35mg tablets, Naltrexone HCl 50mg tablets, Isradipine 2.5mg and 5mg capsules, Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets, Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules, among others.
Revenue Growth: Elite Pharmaceuticals reported quarterly revenue of $36.3 million, up 92% from last year, and six-month revenue of $76.5 million, nearly matching all of last fiscal year.
Key Product Drivers: The launch and growth of generic Vyvanse (Lisdexamfetamine) significantly boosted results, with Elite now holding an estimated 8% market share in this product.
Margins & Pricing: Gross profit rose 72% YoY, but margins declined quarter-over-quarter due to increased competition, higher supply, and one-time wholesaler stocking fees.
Strong Cash & Balance Sheet: Operating cash flow for the first six months was $19.9 million (up 333% YoY) and working capital increased 63% to $75 million, while debt continues to decrease.
Product Pipeline: Multiple products in the pipeline include pending FDA review for generic OxyContin ER, a planned Q1 2026 filing for a generic anticoagulant, and several approved but not yet launched products.
M&A Focus: Management emphasized that mergers and acquisitions are a primary strategic focus, with several companies expressing interest in Elite.
Market Share: Elite commands 19% share in the amphetamine IR market and 12% in amphetamine ER, according to IQVIA data.
