Administration (FDA) approval in April 1998 and was supplied initially by Merck. In 2016, Merck & Co. had $95.3 billion in total assets, $40.3 billion in total equity, $24.3 billion in long term debt, and $13.4 billion in working capital. This same year Merck & Co spent $20 billion total split virtually evenly between research and development (R&D) and marketing efforts. Cosopt had annual sales of $342 million during the 12 months before June 2008. In September 2013, Merck & Co. sold the U.S. rights to their ophthalmic product line (including Cosopt) to Akorn Inc. for $52.8 million cash. Upon the original patent expiration, Hi-Tech Pharma was the first of many generic competitors to submit an abbreviated new drug application (ANDA) for dorzolamide hydrochloride/timolol maleate eye drops. Hi-Tech Pharma's ANDA was approved on 28 October 2008. At the time, controversy surrounded the approval of this first ANDA. Hi-Tech sued the FDA for their right to 180 market exclusivity as laid out in the Hatch-Waxman Act. Apotex, another firm seeking an ANDA approval for generic Cosopt, argued that Hi-Tech "forfeited its rights to market exclusivity because it has failed to market the drug within 30 months of its ANDA submission or within 75 days after Merck withdrew its patent information." The FDA upheld their previous exclusivity decisions on acarbose and granisetron, allowing both Hi-Tech and Apotex to make a generic version of Cosopt. Soon after, ANDAs from Sandoz, Bausch & Laumb, TEVA and others were also approved. Just over a year before Merck sold their ophthalmic line to Akorn, Akorn developed a new formulation of dorzolamide hydrochloride/timolol maleate called Cosopt PF, which is simply a preservative free formulation of Cosopt. It gained FDA approval in July 2012 and is currently protected by market exclusivity. Society and culture Legality In the United States, Cosopt, as well as its generics, is only available to patients with a valid prescription. Cost The brand name Cosopt currently costs upwards of $200 after discounts while the generic formulation costs around $70 cash. The more recent preservative free formulation can be purchased for less than the original brand name formulation at around $160 References External links Drug information from the NIH Wikipedia medicine articles ready to translate Ophthalmology drugs Combination drugs Merck & Co. brands