Recent Generic Approvals and Launches

Generics of Chantix, Durezol, Eliquis, and injection potassium/sodium are approved while generics of Tegretol and Levophed are launched.

First generic of Chantix is approved.

The FDA has approved the first generic version of Chantix (varenicline), Pfizer's smoking cessation product. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved August 11, 2021. The generic will come in doses of 0.5 mg and 1 mg.

Upsher-Smith launches generic of Tegretol.

Upsher-Smith Laboratories has launched carbamazepine extended-release tablets, USP in 100 mg, 200 mg and 400 mg strengths. This is the generic of Novartis’ Tegretol XR, which is used to treat patients with seizures and nerve pain from diabetic neuropathy. It is also used to treat bipolar disorder. The carbamazepine extended-release tablet market had U.S. sales of about $120 million for the 12 months ending June 2021, according to IQVIA

Cipla’s ophthalmic generic is approved.

Cipla Limited has received final FDA approval for its abbreviated new drug application for difluprednate ophthalmic imulsion 0.05%, the first generic version of Novartis’ Durezol. The therapy is used to treat inflammation and pain associated with ocular surgery, as well as ocular inflammatory disorders. According to IQVIA, Durezol had U.S. sales of about $106 million for the 12-month period ending June 2021.

Breckenridge launches one generic and gets FDA nod for another.

Breckenridge Pharmaceutical has launched norepinephrine bitartrate injection, a generic for Pfizer’s Levophed, which is used to treat life-threatening low blood pressure. Breckenridge will market the product in its own label and offer 4 mg/4 mL (1 mg /mL) strength in cartons of 10 vials.According to industry sales data, Levophed and its generics had annual sales of $65 million during the 12 months ending June 2021.

Breckenridge has received final FDA approval of its ANDA for apixaban tablets, the generic for Eliquis from Bristol Myers Squibb, for the treatment and prevention of blood clots and stroke. This generic product was developed by Towa Pharmaceutical in its manufacturing facility located in Spain. According to industry sales data, Eliquis generated annual sales of $14 billion during the 12 months ending May 2021.

FDA approves potassium/sodium for injection.

Fresenius Kabi USA received approval potassium chloride in 5% dextrose and 0.225% sodium chloride injection, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) in single-dose containers. It is used to treat patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.