FDA approves first generic RECTIV ointment by Cosette Pharmaceuticals

In a landmark move for the pharmaceutical industry, Cosette Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV (nitroglycerin) ointment, 0.4%. This approval not only marks a significant milestone for Cosette but also triggers a 180-day Competitive Generic Therapy (CGT) exclusivity period, during which Cosette will be the sole distributor of this generic medication.

Apurva Saraf, President and CEO of Cosette Pharma, expressed pride in this achievement, highlighting it as a pivotal product approval that underscores the company’s commitment to research and development (R&D), operational excellence, and innovation. Saraf stated, “This is a pivotal product approval, and a testament to our unwavering dedication to R&D, operational excellence, and innovation. This is Cosette’s 24th new product launch and our 3rd CGT approval in the last two years.” The launch is a direct result of Cosette’s robust R&D efforts, supported by state-of-the-art In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) laboratories, and its manufacturing facility in Lincolnton, NC.

Cosette Pharmaceuticals, Inc. Secures Exclusive Rights to Market First Generic Version of RECTIV Nitroglycerin Ointment. Photo courtesy of Business Wire.

With several products in active development and multiple complex product ANDAs pending FDA approval, Cosette is positioned to continue its legacy of delivering high-quality, affordable medications. The introduction of the generic RECTIV ointment is expected to bolster Cosette’s quality track record and leverage its U.S.-based manufacturing capabilities.

According to data from IQVIA, U.S. annual sales of nitroglycerin ointment 0.4% for the 12 months ended January 2024 were approximately $21.2 million. The approval of Cosette’s generic version of RECTIV, a registered trademark of AbbVie, is poised to offer a more affordable option to patients, potentially reshaping the market landscape for this essential medication.

The FDA’s approval of Cosette’s generic RECTIV ointment represents a significant advancement in the availability of affordable healthcare options. The 180-day exclusivity period not only highlights the importance of CGT in encouraging pharmaceutical innovation but also demonstrates the FDA’s commitment to supporting companies like Cosette that invest in bringing high-quality generic medications to the market.

This approval is a testament to Cosette Pharmaceuticals, Inc.’s dedication to excellence in pharmaceutical development and its strategy to leverage comprehensive R&D and manufacturing capabilities to meet the healthcare needs of the U.S. population.