The US Food and Drug Administration (FDA) has over the years come up with initiatives to protect the interests of both the patented and generic drug manufacturers. The FDA has come up with a new approval pathway which is the Competitive Generic Therapy (CGT) directed solely towards pushing generic players to enter the market and improving affordability of older off patent medicines for the public. This program introduced under section 506h of Federal Food, Drug and Cosmetics Act and 21 United States Code Section 356h was as recommended by the FDA Reauthorization Act of 20171.
Competitive Generic Therapy is an initiative to foster generic drug development and approval by bestowing with the Abbreviated New Drug Applications (ANDA) filer a CGT designation, if a particular generic drug has only one approved generic alternative. This is indicative of the fact that there is inadequate competition and the FDA wants to boost generic competition in a relatively unexplored market through this program. The first ANDA filer to receive approval under the CGT initiative acquires benefits like expedited review process of their ANDAs and eligibility for 180 day exclusivity period which is similar to the exclusivity provided for Para IV filers contesting the validity of an innovator; not to mention the trade margins gained in the bargain. However, the downfall is that, unlike the latter, a CGT exclusivity does not block the approval of other ANDAs until the ANDA filer with CGT status starts commercially marketing the drug and therefore it is strongly recommended that the launch of the CGT designated drug take place within 75 days from approval.
Apotex was the first company to obtain a CGT approval in August 2018 for the oral drug Potassium Chloride oral solution 10% (20mEq/15mL) and 20% (40mEq/15mL). Potassium chloride is an oral treatment indicated for treating and preventing hypokalaemia (low potassium blood levels) in patients taking diuretics and when dietary management with potassium-rich foods is insufficient or the diuretic dose cannot be reduced. Another case of CGT approval is that for Methylergonovine Maleate Tablet, 0.2 mg granted to Amneal Pharma, wherein Novel Laboratories was the only generic player in the market until 2018. Glenmark Pharmaceuticals was the most recent recipient of the CGT approval for its Hydrocortisone Valerate ointment USP, 0.2%. This approval not only led to an increase in its share price but also contributed to an 11% increment in the company’s US business for the financial year 2018-2019.
Some of the drugs which are off patent and which can potentially receive CGT designation are Acetaminophen solution, mesalamine extended release capsule, vigabatrin tablet, etc. There is a need for the FDA to create awareness about such old molecules so that ANDA filers are driven to invest time and money in developing generic versions so that the public is benefitted.