Filing Analysis
Elite Pharmaceuticals announced the launch of its generic version of Vyvanse (Lisdexamfetamine Disylate) in multiple strengths for the treatment of ADHD. The product is being marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic version of Vyvanse® (Lisdexamfetamine Disylate).
- Indications: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).
- Dosage Strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules.
- Marketing Label: Elite Laboratories, Inc.
Elite Pharmaceuticals announced the launch of its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets) in multiple strengths. The product is being marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII).
- Dosages launched: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg tablets.
- Marketing Label: Elite Laboratories, Inc.
Elite Pharmaceuticals, Inc. announced that the FDA approved a generic version of Vyvanse® (Lisdexamfetamine Dimesylate) in multiple strengths on November 15, 2024. The product will be marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- FDA approval received on November 15, 2024.
- Product: Generic version of Vyvanse® (Lisdexamfetamine Dimesylate).
- Strengths approved: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules.
- Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).
- Marketing label: Elite Laboratories, Inc.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ending September 30, 2024. The company also scheduled a conference call and business update for November 15, 2024.
📋 Key Facts
- Filed Form 10-Q for the quarter ended September 30, 2024 on November 14, 2024.
- Scheduled a conference call and general business update for November 15, 2024, at 11:30 AM EST.
- The company will address stockholder questions during the scheduled call.
Elite Pharmaceuticals announced that the Israeli Ministry of Health has approved its generic version of Adderall® (amphetamine salts) for use in Israel. The company will manufacture and package the product under a license with Dexcel Pharma, which will handle sales and distribution.
🚩 Red Flags
- Revenue timing uncertainty: First shipment depends on DEA quotas and manufacturing cycles, potentially delaying cash flow for months.
📋 Key Facts
- Israeli Ministry of Health approval received on October 7, 2024, for generic Adderall® (10mg, 20mg, and 30mg tablets).
- Product is a CNS stimulant indicated for ADHD and Narcolepsy.
- Dexcel Pharma (Israel) will act as the exclusive distributor, handling sales, marketing, and distribution at its own expense.
- Elite Pharmaceuticals will manufacture and package the product under Dexcel's label.
- The product is jointly owned by Elite Pharmaceuticals and Mikah Pharma LLC.
- Revenue realization is subject to DEA quotas, licensee orders, and manufacturing timelines, which may take several months.
Elite Pharmaceuticals announced the launch of its generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate) in three different strengths. The product is marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic Tylenol® with Codeine (acetaminophen and codeine phosphate).
- Dosage Strengths: 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.
- Labeling: Marketed and sold under the Elite Laboratories, Inc. label.
- Filing Date: October 7, 2024.
Elite Pharmaceuticals announced the launch of its generic methotrexate sodium 2.5 mg tablets, marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product Launch: Generic methotrexate sodium 2.5 mg tablets.
- Marketing Label: Sold under the 'Elite Laboratories, Inc.' brand.
- Filing Date: August 27, 2024.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended June 30, 2024, and to schedule a conference call for August 15, 2024.
📋 Key Facts
- Filed Form 10-Q for the quarter ended June 30, 2024.
- Scheduled a business update conference call for August 15, 2024, at 11:30 AM EDT.
- The company will address stockholder questions during the scheduled call.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its Form 10-K for the fiscal year ended March 31, 2024, and a subsequent press release regarding financial results.
📋 Key Facts
- Company filed its annual report (Form 10-K) for the fiscal year ending March 31, 2024.
- A conference call is scheduled for July 2, 2024, at 11:30 AM EDT to provide a business update and answer stockholder questions.
- The filing includes an exhibit (99.1) containing the press release with financial results.
Elite Pharmaceuticals, Inc. entered into an Asset Purchase Agreement with Nostrum Laboratories Inc. to acquire rights to three approved ANDAs and manufacturing technology.
📋 Key Facts
- Acquisition of ANDA rights for generic Norco (Hydrocodone/Acetaminophen), Percocet (Oxycodone/Acetaminophen), and Dolophine (Methadone).
- The transaction includes a royalty-free, non-exclusive perpetual license to manufacturing technology and proprietary processes.
- Total consideration is $900,000 in cash.
- Transaction closed on June 21, 2024.
Elite Pharmaceuticals Inc. announced a change in its independent registered public accounting firm due to a merger/transaction between Mazars USA LLP and Forvis, LLP. As a result of this transaction, Forvis Mazars, LLP will now serve as the Company's auditor effective June 1, 2024.
🚩 Red Flags
- None identified; the auditor change is a direct result of a firm merger rather than an internal dispute.
📋 Key Facts
- Mazars USA LLP effectively resigned due to a transaction with Forvis, LLP resulting in the formation of Forvis Mazars, LLP.
- Forvis Mazars, LLP is the successor auditor, recommended by the Audit Committee and approved by the Board.
- The change was effective June 1, 2024.
- The Company stated there were no disagreements with Mazars USA regarding accounting principles, financial statement disclosure, or auditing scope/procedures.
Elite Pharmaceuticals announced on May 20, 2024, that the FDA approved a generic version of Methotrexate Sodium 2.5 mg tablets to be sold under the Elite Laboratories, Inc. label.
📋 Key Facts
- FDA approval received on May 16, 2024.
- Product: Generic Methotrexate Sodium 2.5 mg tablets.
- Drug Class: Antimetabolites.
- Labeling: To be sold under the Elite Laboratories, Inc. label.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended December 31, 2023, and a corresponding press release regarding financial results.
📋 Key Facts
- Filed Form 10-Q for the quarter ended December 31, 2023.
- Issued a press release announcing quarterly financial results on February 14, 2024.
- Scheduled a conference call and business update for February 15, 2024, at 11:30 AM EST.