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Generic version of Durezol launches in US

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2 min read

Dr. Reddy’s Laboratories announced it is launching Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05%., a therapeutic generic equivalent to Durezol (difluprednate ophthalmic emulsion 0.05%), to the US market.

Give me a refresh on Dr. Reddy’s

The multinational pharmaceutical company is based in Hyderabad, India, with a portfolio including generics, branded generics, biosimilars, and over-the-counter products. They largely focus on therapeutic areas such as gastrointestinal, diabetology, cardiovascular, oncology, pain management, and dermatology, with a presence in the US market as well as in India, China, Brazil, and Europe.

Now tell me about Durezol.

A registered trademark of Novartis, Durezol is a topical corticosteroid indicated for treating inflammation and pain associated with ocular surgery and endogenous anterior uveitis.

For ocular surgery, one drop is instilled into the conjunctival sac of the affected eye, QID, starting 24 hours after surgery and continuing postoperatively for two weeks, then for twice a day for a week followed by a taper down schedule based on response. For uveitis, one drop is instilled into the affected eye’s conjunctival sac, QID, for 14 days, then followed by a taper-down regimen dependent on case presentation.

See here for complete prescribing information.

What about Dr. Reddy’s formulation?

Recently approved by the FDA, the formulation is also indicated for treating inflammation and pain associated with ocular surgery as well as endogenous anterior uveitis. Similar to Durezol, the product is available in 5 ml bottles in case packs of 24.

What does this mean for Durezol?

According to the IQVIA, Durezol and the generic accumulated an estimated $40 million MAT (moving annual total) in U.S. sales for the 12-month period ending in November 2022.

With a similar formulation and indication comparative to the branded version, it will likely be less expensive, which might minimize certain barriers such as insurance prior authorization requests— leading to potential improvements in insurance coverage and overall patient access.

Stay tuned for more pricing details.