A New Era for Actinic Keratosis Treatment: Extrovis and Dr. Reddy's Unveil Authorized Generic of CARAC® Cream

In a significant stride forward for dermatological care, Extrovis AG and Dr. Reddy's Laboratories, Inc., a wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., have jointly announced the highly anticipated U.S. launch of the authorized generic version of CARAC® (fluorouracil) Cream, 0.5%. This pivotal collaboration marks a new chapter in providing accessible and affordable treatment options for patients suffering from actinic keratosis.

Actinic keratosis, a common precancerous skin condition caused by chronic sun exposure, affects millions of individuals annually and, if left untreated, can progress to squamous cell carcinoma.

The introduction of this authorized generic stands to make a substantial impact, offering a cost-effective alternative to the brand-name product, thereby expanding patient access to crucial therapy.

The authorized generic, Fluorouracil Cream, 0.5%, mirrors the formulation, strength, dosage form, and route of administration of its reference listed drug, CARAC®.

This ensures that patients receive a product with the same high quality and efficacy profile as the branded version, but at a potentially more economical price point. This launch underscores the commitment of both Extrovis AG and Dr. Reddy's to enhance healthcare accessibility without compromising on therapeutic standards.

The original CARAC® (fluorouracil) Cream, 0.5% has been a cornerstone in the topical treatment of actinic keratosis.

The market for this product has shown robust demand, with U.S. sales of CARAC® estimated at approximately $60.3 million for the twelve months ending May 2025, according to IQVIA. The entry of an authorized generic is poised to introduce healthy competition into this segment, ultimately benefiting consumers through increased availability and competitive pricing.

“We are thrilled to bring this authorized generic of CARAC® to the U.S.

market in partnership with Extrovis AG,” stated a spokesperson for Dr. Reddy’s Laboratories. “This launch exemplifies our dedication to making high-quality medicines more affordable and available to patients. We believe this will be a valuable addition to the dermatological treatment landscape, offering relief and preventative care to those at risk of progressing actinic keratosis.”

This strategic launch not only highlights the effective collaboration between Extrovis AG and Dr.

Reddy's but also reinforces the growing importance of authorized generics in bridging the gap between innovative brand-name drugs and the need for cost-effective alternatives in the healthcare system. Patients and healthcare providers can now look forward to a more accessible option in the fight against actinic keratosis, paving the way for improved public health outcomes.