ORDERI. Introduction On December 5, 2017, plaintiff Provepharm, Inc. (“plaintiff’ or “Provepharm”) commenced this action against defendant Akorn, Inc. (“defendant” or “Akorn”), seeking, inter alia, damages and injunctive relief for Akorn’s allegedly false advertising of its methylene blue product in violation of Section 43(a) of the Lanham Act, 15 U.S.C. §1125(a), and Section 350(e)(3) of the New York General Business Law; unfair competition in violation of Section 43(a) of the Lanham Act, 15 U.S.C. §1125(a), and the common law; and deceptive trade practices in violation of Section 349(h) of the New York General Business Law.1 Issue was joined by the service of an answer on behalf of Akorn on or about February 5, 2018. On August 27, 2018, Akorn served an amended answer, inter alia, asserting two (2) counterclaims against Provepharm seeking damages and injunctive relief for Provepharm ‘s alleged monopolization and attempted monopolization of the methylene blue market in the United States in violation of Section 2 of the Sherman Act, 15 U.S.C. §2. Pending before the Court, inter alia, are Provepharm’ s motion to dismiss Akorn’ s counterclaims in their entirety pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure for failure to state a claim for relief; and Akorn’s motion pursuant to Rule 15(a)(2) of the Federal Rules of Civil Procedure to amend its counterclaims. For the reasons set forth below, Provepharm’s motion to dismiss is denied and Akorn’s motion to amend is granted.II. BackgroundA. Factual Allegations2This case concerns the drug methylthioninium chloride, also known as methylene blue, (Counterclaim ["Countercl."], 8; Proposed Amended Counterclaims ["PAC"], 8), which was originally developed in the nineteenth (19th) century and has been used clinically as both a dye and a medication to treat a variety of conditions, including methemoglobinemia. (Complaint ["Compl."], 14; Amended Answer ["Am. Ans."], 14; see also Countercl., 8; PAC, 8). Methemoglobinemia is a rare and life-threatening disorder in which blood cells produce an abnormal amount of methemoglobin, which is a modified form of hemoglobin. (Compl., 12; Am. Ans., 12; see also Countercl., 8; PAC, 8). Since the hemoglobin in patients with methemoglobinemia cannot effectively release oxygen to body tissues, those tissues may be deprived of an adequate oxygen supply, leading to tissue hypoxia. (Compl., 13; Am. Ans., 13). Thus, patients with methemoglobinemia can experience cardiac, pulmonary, and neurological symptoms; and, in severe cases, death. (Compl., 13; Am. Ans., 13). Patients with acquired methemoglobinemia can be treated by delivering a solution of methylene blue intravenously, thereby restoring the iron in hemoglobin to its normal oxygen-carrying state. (Compl., 14; Am. Ans., 14; see also Countercl., 8; PAC, 8).Although the only use for methylene blue that is approved by the United States Food and Drug Administration (“FDA”) is for the treatment of methemoglobinemia, “today methylene blue is used by healthcare providers for a multitude of unapproved indications, for example as an antidote for cyanide poisoning, and is often a component in other medications.” (Countercl., 8; PAC, 8).On its website, Akorn describes itself as “a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products[,]…[which] specialize[s] in difficult-to-manufacture sterile and no-sterile dosage forms including: ophthalmics, injectables, oral liquids, optics, topicals, inhalants, and nasal sprays.” (Compl., 33; Am. Ans., 33). Akorn originally began marketing methylene blue in 2009. (Compl., 34; Am. Ans., 34).Provepharm is a competitor of Akorn in connection with the sale of methylene blue injection products in the United States. (Countercl., 4; PAC, 4).Until 2016, all companies that manufactured and sold methylene blue did so under a “grandfather” status, which exempts pre-existing drugs meeting certain criteria from the requirements: (i) of having an approved New Drug Application (“NDA”) under legislation enacted in 1938; and (ii) of proving effectiveness under legislation enacted in 1962. (Countercl.,
9-11; PAC,
