Oakrum Pharma and ANI Pharmaceuticals Announce the Launch of Betaine Anhydrous Powder, the first Generic Version of Cystadane® (betaine anhydrous for oral solution) Powder, Including 180 Days of Exclusivity

On February 14, 2022 Oakrum Pharma, LLC ("Oakrum Pharma"), in collaboration with ANI Pharmaceuticals (NASDAQ: ANIP), reported that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane1 (betaine anhydrous for oral solution) Powder in a 180 gm bottle and granted Competitive Generic Therapy (CGT) of 180 days of exclusivity (Press release, ANI Pharmaceuticals, FEB 14, 2022, View Source;powder-including-180-days-of-exclusivity-301481968.html [SID1234608093]). Shipments of the generic product began in early February, 2022.

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Marco Polizzi, CEO of Oakrum Pharma, stated, "This is the third generic orphan drug that we have launched since starting this business, and we remain committed to bringing rare disease patients affordable options of pharmaceutical products that currently have few or no generic options. Oakrum currently has licensing rights to seven additional ANDAs filed with the FDA and expects to file additional generic orphan drugs later this year."

"Our collaboration with Oakrum furthers ANI’s mission of bringing high-quality prescription pharmaceutical products to patients in need. Rare diseases are often overlooked, and we are especially pleased to continue identifying patient populations that are underserved and medicines that can help them. This approval with Competitive Generic Therapy status and resulting 180 days of exclusivity marks another milestone for ANI’s R&D engine as a leader in bringing limited competition products to market," stated Nikhil Lalwani, CEO of ANI Pharmaceuticals.

1 Cystadane is a licensed trademark of Recordati Rare Diseases Inc.