July 2022: Generic Product News

Iloperidone Tablets

Manufactured by Lupin Limited

Compare to: Fanapt

The FDA has approved Lupin Limited’s abbreviated new drug application for iloperidone tablets at 1-, 2-, 4-, 6-, 8-, 10-, and 12-mg strengths. The drug will be marketed as a generic equivalent of Fanapt (Vanda Pharmaceuticals Inc) in the same strengths and is indicated for the treatment of schizophrenia in adults. It should be taken as directed, starting at a low dose and slowly increasing the dosage. The most common adverse events are dizziness, dry mouth, a stuffy nose, and unusual sleepiness or tiredness. Iloperidone will be manufactured at the company’s facility in India. Data for the 12-month period ending in March 2022 showed that Fanapt had estimated annual sales of $162 million in the United States, according to a statement from Lupin.

For more information: lupin.com

Dabigatran Etexilate Capsules

Manufactured by Breckenridge Pharmaceutical, Inc

Compare to: Pradaxa

The FDA has tentatively approved Breckenridge Pharmaceutical’s abbreviated new drug application for dabigatran etexilate capsules as a generic for Pradaxa (Boehringer Ingelheim Pharmaceuticals, Inc), indicated as a treatment to reduce the risk of blood clots and strokes in adults with atrial fibrillation not caused by heart valve issues and to treat blood clots in the veins of the legs or lungs after the patient receives an injectable medication to treat blood clots for 5 to 10 days. The drug has 3 strengths, 75, 110, and 150 mg, which are equivalent to Pradaxa.

For more information: bpirx.com

Progesterone Injection, USP 500 mg/10 mL

Manufactured by Xiromed LLC

Compare to: Progesterone Injection, USP 50 mg/mL

Xiromed has launched progesterone injection, USP 500 mg/10 mL, which is a generic of progesterone injection 50 mg/mL. It is indicated for the treatment of amenorrhea and abnormal uterine bleeding from hormonal imbalance. The product is packaged in a multiple-dose vial and is the second US product the company has launched from its hormonal injectable facility. Annual sales of Progesterone Injection 50 mg/mL and its generics for the 12-month period ending February 2022 were $20.4 million, according to a statement from Xiromed.

For more information: xiromed.com

Pregabalin Capsules

Manufactured by Lupin Limited

Compare to: Lyrica

The FDA has approved Lupin Limited’s abbreviated new drug application for pregabalin capsules in 25, 50, 75, 100, 150, 200, 225, and 300 mg as a generic of Lyrica (Viatris) in the same strengths. The drug is indicated to treat diabetic nerve pain, fibromyalgia, pain after shingles, and spinal cord injury nerve pain in adults and for partial-onset seizures in individuals 1 month and older with epilepsy who take 1 or more other drugs for seizures. Common adverse events include blurry vision, dizziness, sleepiness, trouble concentrating, and weight gain. The product will be manufactured at Lupin Limited’s facility in India. According to a company press release, Lyrica has estimated annual sales of $263 million in the United States.

For more information: lupin.com