Biofrontera wins patent ruling against Sun Pharma in dispute

WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI) announced that the U.S. Patent Trial and Appeal Board ruled on February 23 that all challenged claims of Sun Pharmaceutical Industries Inc.’s U.S. Patent No. 11,697,028 are unpatentable, according to a press release statement. Shares currently trade at $0.92, up over 60% year-to-date, reflecting investor optimism around the company’s legal positioning.

The ruling relates to patent infringement proceedings initiated by Sun Pharma in June 2024 against Biofrontera and certain affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission. Sun Pharma alleged infringement of the ’028 Patent and a related patent, U.S. Patent No. 11,446,512.

Biofrontera responded by filing petitions for Inter Partes Review with the Board to challenge the validity of Sun Pharma’s asserted claims. The Board agreed with Biofrontera on all challenged claims of the ’028 Patent.

Sun Pharma retains the right to request a review of the decision or appeal to the United States Court of Appeals for the Federal Circuit. The ruling does not affect Biofrontera’s petition concerning the ’512 patent, which the Patent Office denied review on administrative grounds.

Biofrontera is a biopharmaceutical company that commercializes photodynamic therapy products, including the drug-device combination Ameluz with the RhodoLED lamp series for treatment of Actinic Keratosis. The company conducts clinical trials to extend product use to non-melanoma skin cancers and moderate-to-severe acne. With a market cap of $10.66 million and revenue of $37.16 million in the last twelve months, analysts see significant upside potential with price targets ranging from $3 to $9. For deeper insights into BFRI’s valuation and growth prospects, investors can access the comprehensive InvestingPro Research Report, available for this and 1,400+ other US equities.

In other recent news, Biofrontera Inc. reported record preliminary unaudited revenue for the fourth quarter of 2025, estimated to be between $17.0 million and $17.5 million. This marks the highest quarterly revenue in the company’s history, with a year-over-year growth of 35% to 39%. For the full year 2025, Biofrontera expects revenues to range from $41.5 million to $42.0 million, reflecting an 11% to 13% increase compared to 2024. The company also completed the transfer of FDA approvals for its Ameluz and RhodoLED Lamp Series products, including related intellectual property assets and trademarks. Additionally, Biofrontera announced that its Phase 3 clinical trial for Ameluz photodynamic therapy met its primary endpoint in treating actinic keratoses, showing complete clearance in 45.6% of patients. The company has successfully locked databases for two clinical studies evaluating Ameluz for actinic keratosis and acne vulgaris, with results expected soon. Biofrontera also completed a Phase 1 pharmacokinetics study for Ameluz, assessing systemic exposure during photodynamic therapy. These developments highlight Biofrontera’s ongoing efforts in advancing its treatment options and expanding its market presence.

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