Generic Product News: May 2022

Pharmacy TimesMay 2022
Volume 88
Issue 5

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%

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


Naftifine Hydrochloride Cream, 2%

Marketed by Xiromed

Compare To: Naftin

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


Sevelamer Hydrochloride Tablets 400 mg

Marketed by Lupin Limited

Compare To: Renagel

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



Marketed by Alembic Pharmaceuticals

Compare To: Biaxin Filmtab

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


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