Generic New Products October

In this month’s generic roundup, Cipla and Lupine have expanded with new products.

lenalidomide capsules

Marketed by Cipla

Compare with: Revlimid

The FDA approved Cipla’s abbreviated new drug application for lenalidomide capsules in 4 dosages: 5 mg, 10 mg, 15 mg and 25 mg. The capsules are the generic version of Revlimid (Bristol Myers Squibb). The immunomodulatory prescription drug can be used as monotherapy for adults with hematological malignancies and combined with first-line or maintenance therapy or in relapse. Lenalidomide is indicated for the treatment of cancers such as follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, multiple myeloma and myelodysplastic syndrome. Lenalidomide should not be prescribed to children or pregnant women and cannot be used to treat patients with chronic lymphocytic leukemia.

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Diclofenac Sodium Topical Solution USP 2%

Marketed by Lupin

Compare with: Pennsaid topical solution 2%

The FDA has approved Lupin’s Abbreviated Marketing Authorization Application for Diclofenac Sodium USP Topical Solution 2%, which is the generic equivalent of Horizon Therapeutics’ Pennsaid Topical Solution 2%. Pennsaid is a nonsteroidal anti-inflammatory drug indicated by the FDA for treating signs and symptoms of osteoarthritis in the knees. The most common side effect researchers observed with Pennsaid was an application site reaction. The generic version of the drug has estimated annual sales of $484 million in the United States, according to the company.

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Rifaximin 200 mg tablets

Marketed by Norwich Pharmaceuticals

Compare with: xifaxane

Rifaximin 200 mg tablets, indicated for the treatment of travelers’ diarrhea, have received preliminary approval from the FDA. Rifaximin is not expected to hit the US market until July 2029, as a patent for Bausch Health Cos’ reference product Xifaxan will only expire then. Alvogen’s Norwich Pharmaceuticals, which has filed an abbreviated application with the FDA for a new drug for the generic diarrhea tablets, is unlikely to commercialize the product until the original patent expires.

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Adapalene and benzoyl peroxide topical gel 0.3%/2.5%

Marketed by Alembic Pharmaceuticals

Compare with: Epiduo Forte

The FDA approved a new drug application for adapalene and benzoyl peroxide topical gel 0.3%/2.5%. Topical treatment is indicated for the treatment of acne vulgaris in patients 12 years and older. The reference product is the Epiduo Forte topical gel developed by Galderma Laboratories. According to Alembic Pharmaceuticals, adapalene and benzoyl peroxide topical gel 0.3%/2.5% had an estimated market size of US$211 million as of March 2022.

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