Impax Laboratories, Inc. is a publicly traded company listed on the NASDAQ Stock Market LLC under the symbol, “IPXL”, is a specialty pharmaceutical company focused on developing, manufacturing and marketing generic and branded products. The company is headquartered in Hayward, California and has additional offices and facilities in New Jersey, Pennsylvania and Taiwan, R.O.C.
The company’s predecessor entity, privately held Impax Pharmaceuticals, Inc., was founded in 1995. Publicly traded Global Pharmaceutical Corporation and Impax Pharmaceuticals, Inc. completed a reverse merger, forming Impax Laboratories, Inc. on December 14, 1999.
The merger combined the advanced drug delivery systems developed by Impax Pharmaceuticals through its research and development capabilities with Global Pharmaceutical’s sales, marketing and distribution capabilities.
In March 2015, Impax completed its acquisition of Tower Holdings, Inc. (including operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC including its Adrenaclick epinephrine autoinjector), and Lineage Therapeutics Inc. In connection with the closing of the acquisition, Impax reshaped the operating and reporting structure of its two divisions into Impax Generics and Impax Specialty Pharma.
In June 2016, the company acquired 15 marketed generics, as well as three others which are close to market, for $586 million from Teva Pharmaceutical Industries.
In October 2017, the company announced its intention to merge with Amneal Pharmaceuticals LLC in an all stock transaction, creating the fifth largest US generics company, with an expected value fo $6.4 billion. As part of the deal Impax shareholder will own 25% of the new merged entity, with the other 75% going to Amneal's shareholders, with the merged entity taking on Amneal's name - being called Amneal Pharmaceuticals, Inc.
Impax Generics includes the company’s legacy Global Pharmaceuticals business as well as the acquired CorePharma and Lineage Therapeutics businesses. Impax Specialty Pharma includes the legacy Impax Pharmaceuticals business as well as the acquired Amedra Pharmaceuticals business.
Impax’s Generics Division focuses on a broad range of therapeutic areas, including products having technically challenging drug-delivery mechanisms or unique product formulations. In addition to developing solid oral dosage products, the company’s portfolio includes alternative dosage form products, primarily through alliance and collaboration agreements with third parties.
The company’s Specialty Pharma Division is focused on the development and promotion, through the company’s specialty sales force, of proprietary branded pharmaceutical products for the treatment of Central Nervous System disorders and other select specialty segments.
The Impax Specialty Pharma Division currently has one internally developed branded pharmaceutical product, RYTARY (IPX066), an extended release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication, which was approved by the FDA on January 7, 2015.
Several wholesale lots of Impax's 200 mg fenofibrate capsules were recalled in March 2011.
Impax and DAVA Pharmaceuticals engaged in a legal dispute with Purdue Pharma over the patents and production of time-released oxycodone (OxyContin) until reaching an agreement in April 2007. Another dispute with Endo Pharmaceuticals and Penwest Pharmaceuticals concluded with Impax gaining the right to begin producing extended-release oxymorphone through its Global Pharmaceuticals division as of 2013.
Impax announced the resolution of its FDA warning letter for its Hayward, CA facility on September 8, 2015.
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