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 Pharmas 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