Generic News: May 2022

This month’s generic product news features clarithromycin, sevelamer hydrochloride and metronidazole.

Metronidazole Vaginal Gel 0.75%

Marketed by Glenmark Pharmaceuticals

Compare to: MetroGel-Vaginal Gel, 0.75%

Metronidazole Vaginal Gel, the generic version of MetroGel-Vaginal Gel from Glenmark Pharmaceuticals, 0.75% (Bausch Health), has been approved by the FDA. Data for the 12-month period ending November 2021 showed MetroGel-Vaginal Gel had annual sales of approximately $60.4 million, according to a company statement. Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis. Glenmark has 173 products cleared for distribution in the United States, with 46 more awaiting FDA approval.


Naftifine Hydrochloride Cream, 2%

Marketed by Xiromed

Compare to: Naftin

Xiromed has launched Naftifine Hydrochloride Cream 2%, the generic of Naftin (Merz Pharmaceuticals), in partnership with Genzum Life Sciences. The topical cream is indicated for the treatment of tinea corporis, tinea cruris and tinea pedis. Annual market sales of Naftin and its generics for the 12-month period ending December 2021 were approximately $4.1 million, according to a company statement.


Sevelamer Hydrochloride Tablets 400mg

Marketed by Lupine Limited

Compare to: Renagel

The FDA has approved sevelamer hydrochloride, Lupine’s generic version of Renagel from Genzyme Corporation. The product will be manufactured in Lupin’s Indian factory. As of December 2021, annual sales of Renagel are approximately $75 million in the United States. Renagel is indicated for the control of serum phosphorus in people with chronic kidney disease who are on hemodialysis. It comes in the form of 400 mg tablets.



Marketed by Alembic Pharmaceuticals

Compare to: Biaxin Filmtab

The FDA has approved an Abbreviated New Drug Application for Alembic Pharmaceuticals’ clarithromycin tablets in 250 and 500 mg strengths. The tablets are a generic for Biaxin Filmtab in the same strengths of AbbVie. Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by an acute exacerbation of chronic bronchitis in adults. Additionally, they are indicated for acute maxillary sinusitis, community-acquired pneumonia, pharyngitis, tonsillitis, uncomplicated cutaneous and structured skin infections, and other infections. The estimated tablet market size is $11 million over 12 months, according to a company statement.


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