Generic Product News: December


Products include the generic alternatives to Esbriet and Oracea.

Pirfenidone Tablets

Marketed by Camber Pharmaceuticals, Inc

Compare To: Esbriet

Camber Pharmaceuticals has added pirfenidone tablets to its line of generic drugs. The reference drug for the tablets is Esbriet (Genentech). Pirfenidone is indicated to manage idiopathic pulmonary fibrosis. It is available in 2 doses: 267 mg and 801 mg, both in a 90 count bottle. The recommended dosage is 267 mg 3 times daily for the first 7 days of treatment and 801 mg 3 times daily with a meal starting on day 8 of treatment. Adverse reactions include drug-induced liver injury, elevated liver enzyme levels, gastrointestinal disorders, photosensitivity, and rash.

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Doxycycline Capsules

Marketed by Lupin Limited

Compare To: Oracea

The FDA recently granted tentative approval to doxycycline capsules in the 40-mg dose following Lupin’s abbreviated new drug application. Doxycycline capsules are indicated to manage bacterial infections and are the generic equivalent of Oracea (Galderma Laboratories, LP) in the 40-mg dose. The drug manages oral inflammatory lesions, including papules and pustules, caused by rosacea. Oracea had estimated annual sales of $215 million in the United States in 2022, according to the IQVIA report from September 2022.

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Mesalamine Extended-Release Capsules

Marketed by Alembic Pharmaceuticals Limited

Compare To: Apriso

The FDA approved the abbreviated new drug application for mesalamine extended-release capsules in the 0.375-g dose. The reference drug is Apriso (Salix Pharmaceuticals, Inc) in the same strength. Alembic’s mesalamine extended-release capsules are indicated for adults with ulcerative colitis (UC) to maintain remission. The FDA said mesalamine extended-release capsules are for mild to moderately active UC. Adverse events include abdominal pain, diarrhea, dyspepsia, headache, nausea, rash, and vomiting. IQVIA data estimate the US market for this drug at $133 million.

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Drospirenone Tablets

Marketed by Lupin Limited

Compare To: Slynd

The FDA granted tentative approval to Lupin Limited’s abbreviated new drug application for drospirenone tablets in the 4-mg dose. Drospirenone tablets are the generic equivalent of Slynd tablets (Exeltis USA, Inc) in the same strength. Drospirenone tablets are used to prevent pregnancy in females with reproductive potential. Drospirenone is the synthetic form of progesterone, with a similar pharmacological profile to the natural hormone. Slynd is contraindicated in females who have abnormal and undiagnosed uterine bleeding, a history of progesterone sensitive cancers, a predisposition to hyperkalemia, or liver tumors. The estimated annual sales for Slynd are $141 million in the United States, according to IQVIA’s September 2022 report.

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