(a)    In this subtitle the following words have the meanings indicated.

(b)    (1)    “Essential off–patent or generic drug” means any prescription drug:

(i)    For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired;

(ii)    1.    That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or

2.    That has been designated by the Secretary as an essential medicine due to its efficacy in treating a life–threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living;

(iii)    That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and

(iv)    That is made available for sale in the State.

(2)    “Essential off–patent or generic drug” includes any drug–device combination product used for the delivery of a drug for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired.

(c)    “Price gouging” means an unconscionable increase in the price of a prescription drug.

(d)    “State health plan” has the meaning stated in § 2–601 of this title.

(e)    “State health program” has the meaning stated in § 2–601 of this title.

(f)    “Unconscionable increase” means an increase in the price of a prescription drug that:

(1)    Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health; and

(2)    Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of:

(i)    The importance of the drug to their health; and

(ii)    Insufficient competition in the market for the drug.

(g)    “Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.