I strongly suggest new and old investors to read or re-read following post
Just facts
Elite Pharmaceuticals, Inc., a specialty pharmaceutical company, engages in the development and manufacture of oral, controlled-release products, using proprietary know-how and technology, particularly as it relates to abuse resistant products. The company is focusing its efforts on various areas, such as the development of its pain management products; manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications (NDAs) (ANDAs); development of additional generic pharmaceutical products; development of the other products in its pipeline, including the products with its partners; commercial exploitation of its products either by license and the collection of royalties, or through the manufacture of its formulations; and development of new products and the expansion of its licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. The company is focusing on the development of various types of drug products, including branded drug products, which require NDAs under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984, as well as generic drug products, which require ANDAs. The company owns, licenses or contract manufactures various products being sold commercially, such as Phentermine HCl 37.5mg tablets (Phentermine 37.5mg); Lodrane D Immediate Release capsules (Lodrane D); Methadone HCl 10mg tablets (Methadone 10mg); Hydromorphone HCl 8mg tablets (Hydromorphone 8mg); Phendimetrazine Tartrate 35mg tablets (Phendimetrazine 35mg); Phentermine HCl 15mg and 30mg capsules (Phentermine 15mg and Phentermine 30mg); Naltrexone HCl 50mg tablets (Naltrexone 50mg); Isradipine 2.5mg and 5mg capsules (Isradipine 2.5mg and Isradipine 5mg); and Hydroxyzine HCl 10mg, 25mg and 50mg tablets (Hydroxyzine 10mg and Hydroxyzine 25mg and Hydroxyzine 50mg). Phentermine 37.5mg The approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (Epic) dated September 10, 2010. Sales and marketing rights for Phentermine 37.5mg are included in the licensing agreement between the company and Precision Dose Inc. (Precision Dose) dated September 10, 2010 (the ‘Precision Dose License Agreement’). Lodrane D In 2011, the company, along with ECR Pharmaceuticals, launched Lodrane D, an immediate release formulation of brompheniramine maleate and pseudoephedrine HCl, a low-sedating antihistamine combined with a decongestant. Lodrane D is available over-the-counter but also has physician promotion. Lodrane D is one of the adult brompheniramine containing products available to the consumer at this time. Lodrane D is promoted and distributed in the U.S. by Valeant Pharmaceuticals International Inc. Methadone 10mg Tablets Methadone 10mg is contract manufactured by Elite for Ascend Laboratories, LLC, the owner of the approved ANDA. Hydromorphone 8mg Tablets The approved ANDA for Hydromorphone 8mg is acquired pursuant to an asset purchase agreement with Mikah Pharma LLC (Mikah). Sales and marketing rights for Hydromorphone 8mg are included in the Precision Dose License Agreement. Phendimetrazine Tartrate 35mg Tablets The ANDA for Phendimetrazine 35mg was acquired by the company as part of the asset purchase agreement between the company and Mikah, dated August 1, 2013 (the ‘Mikah ANDA Purchase’). Phendimetrazine 35mg is a commercial product being manufactured by the company and distributed by Epic on a non-exclusive basis, and by the company. Phentermine 15mg and 30mg Capsules Phentermine 15mg capsules and Phentermine 30mg capsules are developed by the company, with the company receiving approval of the related ANDA. Sales and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Naltrexone 50mg The approved ANDA for Naltrexone 50mg is acquired by the company pursuant to an asset purchase agreement between the company and Mikah. Sales and marketing rights for Hydromorphone 8mg are included in the Precision Dose License Agreement. Isradipine 2.5mg and Isradipine 5mg The approved ANDAs for Isradipine 2.5mg and Isradipine 5mg are acquired by the company as part of the Mikah ANDA Purchase. Sales and marketing rights for Isradipine 2.5mg and Isradipine 5mg are included in the manufacturing and license agreement between the company and Epic, dated October 2, 2013 (the ‘Epic Manufacturing and License Agreement’). Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg The approved ANDAs for Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are acquired by the company as part of the Mikah ANDA Purchase. Sales and marketing rights for Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are included in the Epic Manufacturing and License Agreement. Approved Products Not Yet Commercialized The company owns seven different approved ANDA’s, all of which are acquired as part of the Mikah ANDA Purchase. Strategy The company’s strategy includes improving off-patent drug products for life cycle management and developing generic versions of controlled-release drug products with high barriers to entry. Research and Development The company incurred total costs of approximately $14.8 million in relation to research and development activities during the year ended March 31, 2015. Patents The company has pending applications for two additional U.S. patents and three foreign patents. Government Regulation and Approval The company is licensed by, registered with, and subject to periodic inspection and regulation by the Drug Enforcement Agency and New Jersey state agencies, pursuant to federal and state legislation relating to drugs and narcotics. History Elite Pharmaceuticals, Inc. was founded in 1984. The company was incorporated in 1997 under the laws of the state of Delaware. The company was reincorporated under the laws of the state of Nevada in 2012.
